Tag Archives: regulatory

JOB: Mill Quality Leader | MS

Title: Mill Quality Leader

Job #767629, Kimberly-Clark Corp.

Location: Corinth MS

Function: Quality & Regulatory Affairs

Reports to: Technical & Quality Team Lead

Position Purpose: 

Provide leadership and coordination for the quality management system, by ensuring ongoing compliance to FDA, ISO 9001, and corporate/sector quality requirements. Also to provide assistance and coordination as needed for issues relative to customer use of the materials and products produced by the mill, with emphasis on preventing customer issues or bringing problems or issues to root cause resolution.

Customers and Customer Expectations:

Customers:  (1) Internal and External Customers who buy or use Nonwoven materials and products (2) Business Units; (3) Mill Management; (4) Mill Associates and Resources; (5) Corporate and GNW staff

Customer Expectations:  (1) Ensure ongoing mill compliance to the FDA, ISO 9001, and Corporate and Sector quality management systems requirements. (2) Ensure any deviations or nonconformances are effectively resolved; (3) Drive continuous improvement in the mill’s quality and customer service performance and in the quality management system (4) Assist with customer related issues and ensure timely and effective resolution

Scope:

  • Reports to the Mill Manager and has dotted-line accountability to a Business Sector Quality Leader.
  • Will be the appointed Quality Management representative for the Corinth Mill and has the responsibility and authority to:
    • Ensure processes needed for the Quality Management System are established, implemented, and maintained.
    • Report to management on the performance of the quality management system and any needed improvements.
    • Ensure the promotion and awareness of regulatory and customer requirements.
  • Works in concert with other Quality Management Representatives to provide a coordinated effort for common Quality Management Systems across the Global Nonwovens sector while ensuring that the Corinth Mill meets FDA, ISO 9001, and sector and corporate quality requirements.
  • Leads or is highly involved in continuous improvement efforts for sector quality initiatives
  • Works with customers and manufacturing teams to ensure satisfaction with the materials and products produced and effective resolution to customer satisfaction issues.
  • Fulfills the role of:
    • The Management Representative as defined in ISO 9001:2008
    • 21 CFR 820, section 820.20 (3) Management Representative
    • MHLW Ministerial Ordinance No. 169, 2004, Article 65 Responsible Engineering Manager
    • Other regulations or standards which require a Management Representative to be the individual responsible for the location Quality Management System and supporting quality activities designed to comply with applicable regulations and/or standards.

Interested in this job? You can contact Dorothy.Beach@KCC.com to receive more information on this job.   Sending your resume would jump-start our process and could lead to a screen call.

Qualifications/Education/Experience Required:

  • Requires knowledge and ability typically associated with a college education related to quality, engineering, statistics, and/or at least 3 years of operational leadership in a manufacturing environment.
  • The incumbent must be able to communicate with customers at all levels from the Mill Manager to the person on the manufacturing floor and possess communication skills for all situations.
  • Must have working knowledge of quality system requirements and ability to ensure ongoing compliance.
  • This person typically has an in-depth knowledge of a single functional area and a working knowledge of many areas.
  • Must be able to travel an appropriate amount of time to have a firsthand knowledge of our customers and their processes (<25% expected).

PRINCIPAL ACCOUNTABILITIES:

  • Act as the Quality Management Representative.
  • Maintain and enhance the Quality Management System to ensure ongoing compliance with the FDA Medical Device, ISO 9001 requirements, as well as the Corporate and sector Quality Management System Requirements.
  • Act as host for the ISO, FDA, Corporate, or GNW Sector Quality Audits.
  • Manage the Internal Assessment, Management Review, Complaint Handling, and Corrective/Preventative Action process.
  • Provide direction and coordination of efforts of the Quality Assurance Resources to ensure overall effectiveness in Quality Assurance support of the manufacturing departments and to proactively identify and execute quality improvement programs.
  • Provide direction and coordination of the Customer Service Coordinator to ensure overall effectiveness and timeliness in complaint investigation and resolution. Encourage and drive mill teams to take ownership of customer satisfaction and to proactively execute customer service improvement programs. Through networking with customers, the mill teams, and the other Nonwovens Mills, anticipate potential customer service issues and drive to resolution.
  • Accountable for ensuring design transfer activities for product/process changes occurs to ensure critical to quality variables meet quality capability and consistency goals.
  • Accountable for getting to root cause of Operational Customer Quality Events and Major Quality Nonconformance.
  • Responsible for developing process verification/validation skills within the R&E teams and Mill teams.
  • Involved in the maintenance and updates to design history and risk management files.
  • Participate in the GNW Sector Quality Capability Team and other Sector teams as needed to drive standardization and business systems improvement across the board, such as the Change Control Team.
  • Support the mill’s EHS policy; comply with all local EHS legislation and codes; identify, report, investigate and address any EHS substandard acts and/or conditions; and drive the setting of EHS objectives and evaluate the effectiveness of the mill’s EHS Management System.
  • Ensure the communication, implementation, and promotion of the World Class Manufacturing values, vision, mission, and foundations as a means for delivering manufacturing results.
  • Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

 

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people – nearly a quarter of the world’s population – trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work.  If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.

 

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

K-C requires that an employee have authorization to work in the country in which the role is based.  In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization.  However, based on immigration requirements, not all roles are suitable for sponsorship.

Global VISA and Relocation Specifications:

K-C will support global relocation for the chosen candidate for this role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-C’s applicable mobility policies. The benefits/policy provided will decided in K-C’s sole discretion. Compensation may vary by location.

Ever wonder what it is like to belong to this global company?  Here are some reasons to join us: http://bit.ly/WorkingatKC !  K-C is known for their employee career development – about 65% of open jobs are filled internally and we hope we can unleash the power in you!

JOB: LAO Regional Ethics & Compliance Leader

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Title: LAO Regional Ethics & Compliance Leader

Job #759797, Kimberly-Clark Corp.

Location: Roswell GA

Function: Legal

Reports to: Chief Ethics & Compliance Officer

Ever wonder what it is like to belong to this global company?  Here are some reasons to join us: http://bit.ly/WorkingatKC !  K-C is known for their employee career development – about 65% of open jobs are filled internally and we hope we can unleash the power in you!

JOB DESCRIPTION

  • Manage, maintain, enforce, monitor, and evaluate the compliance program in the region in coordination with the Chief Ethics & Compliance Officer and regional leadership team
  • Partner with the regional leadership team on compliance matters to (i) ensure regional compliance with K-C’s Code of Conduct, laws, regulations, standards, guidelines, and best practices, (ii) embed the compliance program and K-C’s culture in the region and (iii) make sure the right messages and controls are cascaded throughout the region
  • Stay abreast of new rules and regulations and trends in the industry and region; review, understand and analyze the impact to the business and compliance program and; share information to the business and Chief Ethics & Compliance Officer
  • Establish effective working relationships and build credibility within the region to support a culture of ethics & compliance
  • Serve as compliance regional point of contact and be visible and accessible to employees in the region
  • Manage the implementation of various compliance initiatives and campaigns to drive awareness and knowledge in the region
  • Lead specific projects to enhance compliance program and assist with special projects as needed
  • Work closely Ethics & Compliance Leaders from the other regions to share information and knowledge
  • Identify and evaluate the necessary programs, processes, and resources to maintain and improve the compliance program in the region

Risk Assessment

  • Conduct periodic assessment of compliance risks in the region while developing auditing, monitoring, and oversight processes to ensure mitigation
  • Manage the risk-exposure in the region by ensuring compliance with all relevant laws, regulations, government or regulatory body
  • Oversee the implementation of corrective actions and monitoring in response to identified issues
  • Provide regular updates on the status and effectiveness of the compliance program key risks and mitigation activities to regional leadership and Chief Ethics & Compliance Officer in collaboration with other functions

HelpLine

  • Implement policies and procedures and set the environment that encourages employees to report compliance concerns without the fear of retaliation in the region
  • Oversee the implementation of corrective actions and monitoring in response to identified issues from HelpLine inquiries or from risk assessment mitigation plans
  • Maintain the effective operation of K-C’s Code of Conduct Helpline in the region that allows for anonymous reporting and perform quarterly reviews of the Code of Conduct Helpline to ensure it is operating effectively in the region
  • Collaborate with other K-C departments (Internal Audit, Human Resources, Global Security and Legal) to ensure that reports and other indications of possible misconduct are appropriately and promptly investigated, that appropriate corrective action is taken, including enhancements to the compliance and ethics program, and that the results of these investigations are accurately tracked and maintained

Training and Communications

  • Conduct an annual training and communication needs analysis and develop and implement a compliance training program across the region in collaboration with the Corporate Compliance Program Office and regional owners (HR, Communications, Legal, Finance and Internal Audit)
  • Assist subject matter experts to develop course content for online and in-person/classroom training courses with a specific focus on regional/local type issues
  • Partner with subject matter experts to deliver in-person subject specific compliance training
  • Collaborate with Corporate Compliance Program Office to develop and implement a regional communications plan and to produce regular communications on important compliance news, initiatives, and developments

Evaluating

  • Create, analyze and drive continuous improvements based upon evaluation results from KPIs, audits or surveys in collaboration with the Corporate Compliance Program Office and other relevant K-C departments
  • Undertake strategic projects to continuously improve the efficiency and effectiveness of the regional compliance program in coordination with the regional leadership team 

Interested in this job? You can contact Dorothy.Beach@KCC.com to receive more information on this job.   Sending your resume would jump-start our process and could lead to a screen call.

QUALIFICATIONS

  • 10 plus relevant years working in legal, audit, compliance, risk, and ethics
  • Advanced degree (Juris doctor, Masters) or advanced compliance certifications (CCEP or equivalent) preferred
  • Significant knowledge and experience in implementing training and communications and risk assessment processes and programs
  • Knowledge of industry regulatory standards with strong understanding of anti-corruption or anti-trust
  • Excellent written and verbal executive-level presence to work with the regional leadership team
  • Strong analytical, organizational, problem-solving, and follow-up skills. Ability to interpret rules and guidelines, and then conceptualize and implement into policies, procedures, and controls
  • Excellent and demonstrated project management skills and attention to detail in leading projects and activities in a global organization. Ability to prioritize and work simultaneously on multiple projects and ability to organize and analyze complex information and data
  • Hands-on experience of working in the region, ideally speak a local language, and have native knowledge of local culture
  • Ability to demonstrate sound and independent judgment, prudence and maturity
  • Client orientation with a constructive approach to resolution of issues. A style which builds alliances within the organization

 

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people – nearly a quarter of the world’s population – trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work.  If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

 

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

K-C requires that an employee have authorization to work in the country in which the role is based. In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization. However, based on immigration requirements, not all roles are suitable for sponsorship.

K-C will support global relocation for the chosen candidate for this role, including assistance to obtain proper work authorization. The benefits provided will be per the terms of K-C’s applicable mobility policies. The benefits/policy provided will decided in K-C’s sole discretion. Compensation may vary by location.

Quality Leader, North America Baby and Child Care

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Title:  Quality Leader, North America Baby and Child Care (BCC)

Job #160000Y9, Kimberly-Clark Corp.

Location: Neenah WI (live here: https://www.youtube.com/embed/ljQ6240Klvc)

Can also sit in Roswell GA/ Augusta GA or Maumelle Arkansas

Function: QA/ Regulatory & Compliance

Reports to: VP NA Product Supply

Direct reports: 10-16

Scope: North America, $1.6 billion revenue

 

SUMMARY OF POSITION:

Responsible to develop, implement and maintain BCC NA quality and regulatory systems.  Collaborate with NA and corporate teams to ensure BCC NA meets all quality system and regulatory requirements.  Drive improvement in business processes where quality and regulatory involvement is needed, and advance BCC regulatory interests with key internal and external stakeholders.

 

Scope of this role includes Product Supply manufacturing and staff teams, interface with adjacent business functions (Research & Engineering, Customer Supply Chain and Marketing) as well as corporate entities (Corporate Quality and Legal) and external agencies (FDA) to ensure compliance, understanding of gaps, if any, and providing consultation for purposes of risk management.

 

This position has responsibility for developing and implementing programs, capabilities and initiatives that create the overall quality and regulatory system for the North American BCC business and drive performance and ensure regulatory compliance as it relates to product and process quality.  The incumbent is a key leader in creating capability that ensures compliance, effectively manages risk and enables targeted speed of innovation to market for the North American BCC business.

 

ORGANIZATION: People Responsibilities/ reporting line/partnerships

  • Key relationships include Vice President North American BCC Product Supply, senior BCC R&E leaders, Plant Managers, brand champions, consumer services, material suppliers, procurement, plant operations, corporate quality, corporate communications, risk management, global security, and legal.

KEY RESPONSIBILITIES:

  • Provide expert leadership and consultation to senior BCC leaders and plant managers to create an environment of (1) winning products at shelf and with consumers, (2) minimum variability, and (3) regulatory compliance.
  • Develop, articulate and implement quality management strategies that ensure quality and regulatory capability is an enabler and competitive advantage for BCC to meet business objectives
  • Through training and capability development, ensure a ready and able pool of both functional and broader business talent exists to meet current and future quality and regulatory needs of the BCC business.
  • Demonstrate understanding and provide visibility of industry trends, emerging regulatory requirements and best practices via benchmarking internally and externally and integrate into execution of business-specific quality strategies.
  • Establish quality processes based on prevention, leading indicators and process management that can be owned and managed at the asset/crew level.
  • Establish and manage a comprehensive consumer complaint management, analysis and remediation process.
  • Ensure consistent application of quality standards, governmental and corporate requirements for current and future products.
  • Provide leadership and oversight to continually improve plant operations effectiveness and functionality in the areas of quality and regulatory compliance.
  • Provide leadership for BCC Quality for events that require Crisis Prevention Management.
  • Develop and deliver training to plant and staff that focuses on optimization of quality and regulatory systems and practices.
  • Represent BCC for quality and regulatory matters both internally and externally. 

Ever wonder what it is like to belong to this global company?  Here are some reasons to join us: http://bit.ly/WorkingatKC !  K-C is known for their employee career development – about 65% of open jobs are filled internally and we hope we can unleash the power in you!

Interested in this job? You can contact Dorothy.Beach@KCC.com to receive more information on this job.   Sending your resume would jump-start our process and could lead to a screen call.

MINIMUM REQUIREMENTS:

BA or BS required; MBA or MS as well as certain industry and ISO certifications highly desirable.

More than 12 years of quality and regulatory-related experience, ideally with experience in personal care consumer products / cosmetics regulated manufacturing environment with operating experience in a both a plant and corporate environment. 

Preferred Experience:

  • Includes proven track record of transforming quality and compliance standards to world class levels achieving all regulatory requirements in cosmetic and / or medical device environment.
  • Experience with Lean Six Sigma tools required; Certification (Green or Black Belt) strongly preferred.
  • Experience with significant management of third party manufacturing and suppliers a plus.
  • Demonstrated effectiveness in developing and communicating a quality vision and executing related strategies.
  • Demonstrated ability to assess effectiveness of current organization and develop / implement required plans to improve to world class levels to create advantage position for the business.
  • Demonstrated ability to develop, implement, audit and continuously improve quality systems and results with internal and external manufacturers and suppliers.
  • Business acumen – a clear understanding of the business needs and key imperatives
  • Experience / aptitude for process re-design and organizational change management
  • Demonstrated cross-functional knowledge throughout the supply chain (manufacturing, distribution, planning, sourcing and supply, transportation) including understanding of how quality impacts these areas and the broader business.
  • Demonstrated effectiveness in leading, managing and inspiring in environments of ambiguity.
  • Demonstrated strong leadership and communication skills including the ability to effectively translate complex and highly technical issues into business terminology and clearly articulate key messages, business risks and potential solutions in a way that drives action.
  • Demonstrated track record of initiating and executing change with excellence while demonstrating a positive and contagious energy to promote employee and team member engagement to deliver business results.
  • Demonstrated ability to build talent including accelerated careers of high potential talent, addressing underperformance and consistently growing and stretching all talent through coaching and mentoring.
  • Must be an expert problem solver with a strong bias towards data and analysis and have a firm grasp of Lean Manufacturing principles, systems and tools.
  • Ability to travel by ground and air up to 50% of the time.

 

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people – nearly a quarter of the world’s population – trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work.  If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law.

 

 

 

Kimberly-Clark seeks a Sr. Director of Product Safety and Clinical Affairs

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Title:   Senior Director Global Product Safety and Clinical Affairs

Company: Kimberly-Clark Corporation, Job #1500006V

Location: Neenah WI or Roswell GA

Function: Global Safety, Quality and Sustainability

Reports to: VP Global Quality & Regulatory

Scope: global

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 150 countries. Every day, 1.3 billion people – nearly a quarter of the world’s population – trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With a 135-year history of innovation, we believe in recruiting the best people and putting them in the right jobs so that they can do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.
Position Summary:

This team leader position reports to the Vice-President of Global Quality and is responsible for providing executive leadership to two global teams – Global Clinical Affairs and Global Product Safety. The incumbent will lead these organizations with the remit of ensuring that all Kimberly-Clark products and services sold worldwide are substantiated as safe for their intended use, governmental product safety regulations and meet Company policies and standards and developing clinical evidence and clinical education programs (if needed) in support of the achievement of business strategies and objectives.

Product Safety and Clinical services are provided to all Corporate Functions, Business Sectors and Equity Affiliates of the Corporation worldwide. Management, technical leadership and professional development is provided to team leaders, senior professional and supporting Product Safety, Product Stewardship and Clinical Affairs staff located in Neenah, Roswell, Reigate, JukJeon and other regions as needed.

The incumbent is required to lead a team to  develop and sustain a Global Product Safety approach and clinical strategies that ensure state-of-the-art toxicological  and clinical expertise,  assessments, trials processes and systems are applied that not only ensure product and human safety, but also drive product innovation, sustainability and speed-to-market. The incumbent provides advice to business units based on scientific principles of human health risk assessment or environmental impact with emphasis on helping K-C businesses find viable options and alternatives that are both safe and help achieve Corporate business objectives.

Principal Accountabilities:

  •   Provide consultative, investigative and research services to identify characteristics in the materials and design of Kimberly-Clark products and clinical trials to ensure safety, regulatory and corporate standard compliance.  Recommend steps as necessary to ensure the safety and efficacy of these products and trials thereby minimizing customer dissatisfaction and/or corporate liability and to develop alternative testing methodologies, which can safely be utilized in K-C products and clinical strategies.
  •   Develop, maintain and improve control systems and procedures that ensure that new materials or products are adequately reviewed for their safety prior to authorization to market. Integrate the K-C Product Safety system into the Innovative Management Framework and other Product Development processes so that these systems function efficiently.
  •   Maintain an awareness of the constantly changing safety, regulatory and medico-legal requirements, translating them into consistent, comprehensive policies and strategies and implementing them to ensure products are safe for both the corporation and its customers.
  •   Ensure awareness of newly described potentials for adverse safety effects relating to the Corporation’s products or product components. Recommend actions to resolve adverse impact upon the Corporation.
  •   Ensure expertise, processes and systems are in place to conduct due diligence on behalf of the Company as required.
  •    Develop and administer a system for receiving, storing, and retrieving confidential information from vendors, suppliers and/or customers as necessary for safety evaluation of K-C products. Ensure that the confidentiality of this information is maintained both within and outside the Corporation.

Interested?  You can also contact Dorothy.Beach@KCC.com to receive more information.   Sending your resume can allow a more intelligent discussion between your career goals and Kimberly-Clark’s business needs.

Qualifications:

  • The ideal candidate will have 15+ years of experience in increasingly senior quality positions within the medical device and/or consumer packaged goods industry. S/he must have an excellent understanding of FDA’s quality frameworks as well as a strong network of relationships with its senior representatives. The successful candidate will also have significant expertise working with continuous improvement methodologies, such as Lean and Six Sigma. S/he must possess a thorough knowledge of current quality trends and concepts and be able to determine appropriate solutions to a wide variety of regulatory and quality problems across the company. Finally, demonstrable results in leading a ground-up review of a quality system would be highly valued.
  • The successful candidate for this role will also have a bachelor’s degree from a recognized university, preferably in engineering or the sciences. An MBA or an advanced degree in sciences/engineering would be preferred.

In addition to the above, we would expect the following specific competencies:

o   Technical Expertise. The successful candidate must be technically credible and possess proven experience dealing with all aspects of product safety product safety-related regulatory requirements, and is also knowledgeable of Human Subject Testing and Good Clinical Practices / Code of Federal Regulations (CFRs).

o   Results Orientation. Executives demonstrating this competency have a track record of delivering against a plan and budget. The individual will be energized by a challenge, and will seek out ways to consistently exceed his/her goals. This person will have demonstrated that s/he takes ownership and responsibility for commitments and is able to deliver despite constraints or unexpected obstacles.

o   Collaboration and Influencing. The successful candidate must have demonstrated the ability to effectively work in a global and complex organization and as part of an international team and a multicultural environment. S/he must be able to adapt his/her influencing style to different personality types as well as different business and national cultures. Furthermore, s/he must also facilitate collaboration among others. This means actively engaging colleagues and business partners to make joint decisions, share best practices, and bring internal and external people together across geographical and organizational boundaries to achieve world-class quality results.

o   People Leadership & Development. The successful candidate will be an inspiring people manager who is able to motivate team members. This individual will work through people and groups and empower them, measure their performance, and hold them accountable for their results. This executive will have demonstrated the ability to tailor his/her style and approach to the situation, the cultural environment, and the individual, exhibiting directive or collaborative behavior as circumstances require. Finally, the successful candidate will show the ability to develop the competencies of the organization by acquisition of top talent and development of their team; they find deep satisfaction in knowing they have made an impact on an individual’s life or career.

 

Travel: Approximately 25% of time; international travel required.

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Sr. Clinical Study Manager sought by Kimberly-Clark | WI

 

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Title: Senior Clinical Study Manager

Job #140003EK, Kimberly-Clark Corp.

Location: Neenah WI just south of Green Bay

Function: Global Quality Assurance

Reports to: Director of Clinical Affairs

From brands such as Huggies® and Kleenex® to medical devices and workplace solutions, Kimberly-Clark makes the essentials for a better life. We hold the No. 1 or No. 2 share position globally in more than 80 countries, but we’re not just changing diapers here. Our employees are changing the world for the better with innovative products that create new categories and push existing ones to a higher level. If fresh thinking and a passion to win inspire you, come Unleash your Power at Kimberly-Clark.

Summary

The Sr. Clinical Study Manager (CSM) is responsible for managing the planning, development, and execution of clinical trials, and for coordinating the activities of multi-disciplinary teams to ensure that high quality results are delivered on time and within budget.  The Sr. CSM provides leadership in the development of study related strategy and documentation including but not limited to protocols, investigator brochures, informed consent documents,  monitoring tools, and budgets, and may participate in the preparation of regulatory submissions as needed. The Sr. CSM is responsible for ensuring that clinical studies comply with all policies, procedures, applicable regulations, and Good Clinical Practices (GCP).  Major responsibilities include all aspects of clinical trial management such as study design/development, site selection, site management, and study management / leadership to multi-disciplinary cross functional team members.

Core Responsibilities:

–          Define, communicate, and evaluate clinical study objectives to deliver high quality results

–     Coordinate the development of clinical study documents, including but not limited to protocols, investigator brochures, informed consent documents, project plans, budgets, etc.

–     Coordinate the day-to-day activities of external vendors such as CROs, central laboratories, contract CRAs, etc.

–          Evaluate and report the ongoing progress of assigned clinical studies to K-C leadership

–     Participate in the analysis, summary, and reporting of clinical data for regulatory, marketing, or other purposes

–     Provide subject matter expertise to cross-functional product development teams

–     Conduct background evaluations of scientific literature, competitive landscapes, and other technical subjects as needed

–          Ensure that Trial Master Files are complete, accurate, and audit ready

–     Provide study specific training to members of the clinical study team

–     Convene qualified clinical research personnel appropriate to conduct assigned clinical studies

–     Oversee and assess the selection process and ongoing performance of clinical study sites

Key Relationships:

–          Clinical Research Associates, Clinical Trial Assistants, and Data Managers

–     Kimberly-Clark senior leaders

–     Multi-disciplinary product development teams including Marketing, Research/Engineering, Quality Assurance, and Regulatory Affairs personnel

–     Clinical Study Investigators, Key Opinion Leaders, and associated research staff

Interested? You can contact Dorothy.Beach@KCC.com to receive more information on job #140003EK  .   Sending your resume can allow a more intelligent discussion between your career goals and what Kimberly-Clark needs.

Basic Qualifications:

Training and Experience:  

–     Bachelors of Science degree in a life science or related technical field (e.g., nursing, engineering, biology, exercise science, etc.); or commensurate combination of training and experience in other fields with at least 10 years of direct clinical research experience in the medical device, consumer product, pharmaceutical, or other related industry

–     At least 5 years of experience managing clinical research studies

–    Certified clinical or project management training

Specialized Knowledge: 

–     Ability to interpret basic tabular and graphical clinical data presentations and other technical information

–     Intermediate to advanced applied knowledge of the clinical research process, Good Clinical Practices, FDA regulations governing clinical trials, and international standards for clinical studies (as appropriate to the role)

Preferred Qualifications:

–     Advanced degree in a technical field preferred

–     Prior experience managing clinical studies in the areas of medical devices, pharmaceutical products, or consumer products

 The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Technical Quality Systems Mgr – Global or Multi-site | GA

Title:  Technical Quality Manager   

Job #15166, Kimberly-Clark

Location: Roswell GA

Function: KC Professional R&E

Reports to: Director

 

Abbreviated description.

 

Kimberly-Clark is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 57,000 employees worldwide and operations in 36 countries, Kimberly-Clark posted sales of $20.8 billion in 2011. Kimberly-Clark’s global brands are sold in more than 175 countries. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries.

 

Scope:

This position reports to the Director, Quality Assurance and Regulatory Affairs – KCP and has supervisory responsibilities for the Design Control, Change Control, Copy Approval, Training systems and personnel.  The incumbent is responsible for supporting KCP projects, system development; cost optimization, improved performance, and quality improvement initiatives.  Incumbent provides technical knowledge and guidance to KCP Business Teams as required to meet global Innovation and New Venture as well as product supply objectives.

 

Accountabilities:

1)         Provide global technical quality leadership in design control, change management, document control, copy approval systems; management review system and activity; and training systems to support the development of KCP technical quality systems to meet sector business unit objectives.

2)         Lead and coordinate problem solving situations at KCP and/or with suppliers on KCP change management issues.  Provide advice and counsel to KCP R&E groups and mills on change management procedures and process improvements for regulatory compliance purposes.

3)         Support cost improvement programs to achieve sector/mill cost objectives.

4)         Support specification development which ensures safe, effective, and reliable KCP products.

5)         Establish and maintain internal control within area of responsibility as required by KCP Internal Control policies.

etc

Interested? Or perhaps you know of someone that might be, you can apply directly using this link: http://bit.ly/15166-QualMgr .  You can also contact Dorothy.Beach@KCC.com to receive more information on job # 15166 .   Sending your resume can allow a more intelligent discussion between your career goals and what Kimberly-Clark needs.

 

Qualifications/Education/Experience Required:

 

Requires a Bachelor’s degree in a science, engineering statistics or related discipline and 10+ years broad managerial experience in a Research, Manufacturing, Quality or Regulatory Affairs function.

An advanced degree is desirable. 

Experience should include close working relationships with Business, Marketing, Manufacturing and Research functions. 

In-depth knowledge of applicable regulatory authority requirements for one or more of the following: biocides, personal protective equipment, cosmetics, drugs or medical devices. 

Also required is demonstrated evidence of a solid background of technical knowledge and experience combined with the proven ability to successfully direct projects and influence people at all organizational levels. 

ASQ-CQE, CQM or CRE highly recommended.

 

Kimberly-Clark hiring Director QA-RA for Medical Device | CA

Title:   Director of Quality Assurance and Regulatory

Job #13649

Location: Lake Forest CA (http://1.usa.gov/LifeinLakeForest )

Function: Healthcare: QA/Regulatory/Compliance

 

Kimberly-Clark (NYSE:KMB) is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 56,000 employees worldwide and operations in 35 countries, Kimberly-Clark posted sales of $19.1 billion in 2009. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries.

I-Flow, a Kimberly-Clark Health Care Company, is improving clinical and economic outcomes following surgery by designing, developing and marketing technically-advanced, low-cost drug delivery systems and innovative products for post-surgical pain relief and surgical site care.  More information: http://www.iflo.com/info.php .  The subsidiary has an immediate need for Director of Quality Assurance and Regulatory.

Principal Accountabilities:
• Provide Quality functional and Regulatory Affairs leadership and expertise to Elastomeric Pump and Pain Management Business such that it contributes to the development, manufacture, and distribution of safe and effective products.
• Assure Quality Operations complies with Domestic and International regulatory requirements. Serve as a liaison with FDA or other regulatory agencies.
• Manage and respond to audits by regulators and/or Notified Bodies
• Develop programs and procedures that will provide leadership and direction in assuring successful implementation of staff QA and RA functional systems, and help enhance manufacturing plant prevention-based quality awareness.
• Direct all aspects of plant-based quality including cost process reliability, problem resolution, complaint investigation, document control, CAPA and value improvements.
• Manage product design validation activities to verify that the products are being developed and designed to meet the input requirements.
• Ensure that new products are designed and developed in conformance with internal design control requirements and external regulatory standards.
• Manage the operating expense budget; develop plans for personnel, space and equipment required to meet the demands of the sterility assurance discipline.
• Manage the maintenance of regulatory affairs files such as 510(k)s, device listings, certificates, registrations, and licenses.

 

Interested? Or perhaps you know of someone that might be, you can apply directly using this link: http://bit.ly/13649-QA-RA-iFLOW . You can also contact Dorothy.Beach@KCC.com to receive more information on job #13649.   Sending your resume can allow a more intelligent discussion between your career goals and what Kimberly-Clark needs.

 

Basic Qualifications

• Bachelors Degree in physical sciences or engineering
15 years of management experience in quality systems, product development, and regulatory affairs experience in the Medical Device industry.
• Experience should include in-depth knowledge of all aspects of product realization for medical devices, domestic (FDA) and International regulatory requirements for the medical device industry as well as direct handling of FDA and Notified Body inspections.

Preferred Qualifications

Advanced Degree in physical sciences, engineering or MBA.
ASQ certification in Quality Management, Quality Engineering, and Auditing or equivalent.
A good working knowledge of Spanish would be beneficial.

Reg Affairs & QA Director for GA | Kimberly-Clark hiring

Title:  Director of Regulatory Affairs & Quality Assurance

Job #13017

Location: Roswell GA (http://bit.ly/Roswell-Green )

Function: Quality Assurance/ Regulatory/Compliance

Product Line: KC-Professional (http://bit.ly/K-C_Professional)

 

Kimberly-Clark (NYSE:KMB) is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 56,000 employees worldwide and operations in 35 countries, Kimberly-Clark posted sales of $19.1 billion in 2009. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries.

 

POSITION PURPOSE:
Responsible to develop, implement and maintain global KCP quality and regulatory systems. Collaborate with regional and corporate teams to ensure KCP globally meets all quality system and regulatory requirements. Drive improvement in business processes where quality and regulatory involvement is needed, and advance KCP regulatory interests with key internal and external stakeholders.

CUSTOMERS AND CUSTOMER REQUIREMENTS:
Key customers include consuming customers, sector management, business teams, R&E teams, product supply and quality assurance teams, corporate regulatory affairs and quality assurance teams, external quality and regulatory bodies.

Effective performance in this role will require:
– Strong collaboration, communication and persuasiveness skills
– Credibility with senior leadership internally and regulatory agencies externally
– Working effectively across functional and geographic boundaries through influence
– Visionary and strategy development skills
– Business acumen – a clear understanding of the business needs and key imperatives
– Experience / aptitude for process re-design and organizational change management
– Global breadth of experience and understanding
– Quality systems background

Interested? Or perhaps you know of someone that might be, you can apply directly using this link: http://bit.ly/13017-DirRA-QA  .  You can also contact Dorothy.Beach@KCC.com to receive more information on job #13017.   Sending your resume can allow a more intelligent discussion between your career goals and what Kimberly-Clark needs.

 

Basic Requirements:

– A minimum of a Bachelor’s Degree in a relevant field is required.
– Requires a minimum of 8-10 years experience in an industry dealing with relevant regulatory requirements and leading regulatory or quality systems implementation and management.
– Experience having led or created a team and highly developed leadership capabilities combined with the ability to motivate and lead a diverse team and work in a matrix organization.

PREFERRED QUALIFICATIONS:
– Knowledge of KCP products, processes, and organization or similar industry experience is preferred
– Experience with ISO certification
– Experience with global regulations across multiple countries

K-C looking for a Medical Device TQM Engineer for Lake Forest CA

Position: Sr. Quality Engineer , #11919

Location: Lake Forest CA
Reports to: Director, Global Quality Operations

Kimberly-Clark (NYSE: KMB)  -Healthcare Division provides quality and innovation to enhance people’s health outcomes. We are heavily investing in enhancing our medical device businesses through development of new products and acquisition of medical device companies. Every day, 1.3 billion people in more than 150 countries – nearly a quarter of the world’s population – trust Kimberly-Clark brands and the solutions we provide to enhance their health, hygiene, and well-being. With a 135-year history of success and financial stability, we believe in recruiting smart people and supporting them so that they can do their best work.  In 2009 Kimberly-Clark acquired I-Flow Corporation a leader and innovator in pain management and drug delivery technology for physicians and their patients.

Summary: Conduct quality engineering activities to support the design and development process as well as other quality engineering elements to ensure compliance with I-Flow Quality System. Information on the product line is here: http://bit.ly/iFLOW-products.

Interested for you or a friend?  Please contact me at Dorothy.Beach@KCC.com or leave a message at 469-665-5639 to set up a time to talk. Please refer to job #11919.  You can also directly apply for job #11919 at http://bit.ly/11919-QualEngr after setting up a profile.
Responsibilities:
1. Develop, document, implement and report on the verification and validation of new product and their accompanying processes if applicable.
2. Responsible for supplier assessment oversee outside supplier’s quality.
3. Develop Quality plans for new materials, components and finished medical devices.
4. Demonstrated knowledge and experience with QSR, ISO 13485/ ISO 14791 and MDD.
5. Review Overall manufacturing process and Quality System elements for continuous improvement.
6. Knowledge of failure analysis, (FMEA-Process & Product Design)
7. TQM and SPC (statistical process control), FDA Quality System Regulation.
8. Work with suppliers of material, component or design changes to ensure timely implementation and quality.
9. Create product in process and final inspection procedures that define methodologies used for determining the level of process and product integrity based on all applicable requirements and specifications.
10. Provide receiving inspection with written instruction for inspecting components and assemblies.
11. Support product complaint investigation by performing failure and root cause analysis on products returned from the field.
12. Originate corrective and preventive actions (CAPA) and assist in the implementation of CAPA program.
13. Develop new approaches for solving problems identified during quality assurance activities
14. Support technical and administrative workers engaged in Quality Assurance activities.
15. Lead the MRB in the reporting & disposition of nonconforming materials. Maintain NCMR (non-conforming materials) database. Review corrective actions on NCMRS for adequacy to maintain a continuing awareness of quality issues.
16. Maintain the calibration database system. Assure timeliness and adherence to calibration schedules and equipment. Provide guidance to Mexico operations.
17. Review Protocols and Reports for Process/Product Validations for compliance with procedures.

Basic Qualifications:
Education: Bachelors Degree, CQE Certification desirable

Experience: Three years of related experience in the medical device industry. Analytical, detail oriented team player. Excellent communication, problem solving and project management skills.

Specialized
Knowledge: Microsoft windows (Excel, Word, Outlook). FDA QSR, MDD 93/42/EEC, ISO 13485/ ISO 14791, CMDR, GHTF-Process Validation Guidance.

There is no relocation assistance for this job and local, Southern California residents should apply.  Equal Opportunity Employer.

Kimberly-Clark seeking a Dir Quality Systems for Healthcare | Atlanta | International

Title: DIRECTOR QUALITY SYSTEMS- Roswell, GA (near Atlanta)

Travel: 30% – will need to travel internationally

Kimberly-Clark is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 56,000 employees worldwide and operations in 35 countries, Kimberly-Clark posted sales of $19.1 billion in 2009. Kimberly-Clark’s global brands are sold in more than 150 countries.  Kimberly-Clark ‘s Healthcare Division provides quality and innovation to enhance people’s health outcomes. We are heavily investing in enhancing our medical device businesses through development of new products and acquisition of medical device companies. We have recently acquired two companies focused in the area of pain management to add to our medical solutions.

Position Purpose
This is a key Quality Assurance management position with global responsibility. The incumbent directs the development, implementation and maintenance of the Health Care Sector-wide Quality System. Specific functional areas include, Compliance Assessment, Document Control, Software Validation, Records Retention, Corrective and Preventive Action, Post Market Surveillance, Supplier Quality, and Quality Systems training. Incumbent directs activities focused on resolution of Quality System issues; prepares and distributes reports on the effectiveness of the Quality System; Conducts Divisional Management Reviews of Quality Systems; Manages systems for the technical documentation used to register products with regulatory agencies; Represents Quality in Due Diligence activities related to mergers and acquisitions.

Interested for you or a friend?  Please contact me at Dorothy.Beach@KCC.com or leave a message at 469-665-5639 to set up a time to talk. Please refer to job #10603. More complete information for job #10603 is found at http://bit.ly/10603-Quality .  You can directly apply using this link after setting up a profile.
Dimensions:

Direct Reports: 6 Exempt

Indirect Reports: 20 Exempt

Departmental Budget: $3.5 MM

Global Sales $1.5 Billion

Principle Accountabilities:
1. Directs activities required in the Document Control process for procedures, work instructions and forms.; Directs activities for revision of documents in order to ensure compliance and facilitate efficient business operation
2. Directs the development and maintenance of Quality System training processes.
3. Directs CAPA activities and maintains the CAPA system. Including initiation, support of the root cause investigation, closure, and verification of effectiveness. Ensures compliance to applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, Medical Device Directive, ISO, etc.).
4. Drives continuous improvement processes for the Quality System.
5. Maintains current knowledge base of regulations, corporate policies, and standards to ensure compliance.
6. Directs the Supplier Quality activities; working with Product Supply, develops and uses appropriate supplier selection, qualification, and management strategies.
7. Integrates the Quality System into Merger and Acquisition activities.
8. Directs the Post Market Surveillance activities and reviews data analyzed by the Product Surveillance; Takes appropriate product-related actions based on the analysis.
9. Establish and maintain a strong complaint resolution system through the Product Surveillance process. Interact directly with product supply, marketing, P&TD, and other departments, as required with respect to product failure reporting and investigation.
10. Keeps Senior Management appraised of product related issues.
11. Manage the operating expense budget; develop plans for personnel, space and equipment required to meet the demands of the sterility assurance discipline.
12. Review current programs, assign new programs or program revisions, evaluate progress and results.
13. Develop a highly motivated staff that is organized and structured to most effectively utilize individual and group capabilities.
14. Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported and manage teams and self in accordance with the expected behaviors of the Leadership Qualities to facilitate creativity and innovation, personal growth and business contributions of a diverse work force. Provide performance management for Level 5 team members.

Basic Qualifications:
Bachelor’s Degree required (advanced degree preferred in these areas or an MBA) in physical science or engineering with a minimum of 10 to 15 years Quality System experience in a Medical Device, Diagnostics, or Biotechnology company is required.
Excellent knowledge of the content and application of National and Global Regulatory regulations and consensus standards, including 21CFR 820; 210;211; ISO standards, USP, JP and related country specific regulations.
Well developed problem solving, quantitative, analytical, oral, and written communication skills are required.

Preferred Qualifications:
Certified Quality Engineer
Six Sigma Black Belt preferred

Kimberly-Clark is an Equal Opportunity Employer.