Tag Archives: FDA

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!

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.

 

 

 

Engineering and Manufacturing Operations Leader | New Tech Platform

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Title:  Engineering and Manufacturing Operations Leader for Sofusa

Company: Kimberly-Clark Corporation, job #150002XC

Location: Sandy Springs GA just south of Roswell GA

Function: Corporate Innovation

Reports to: VP of Science and Technology

Product Line: DoseDisc

 

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Most recently, the company has developed the first-of-a-kind Sofusa™ DoseDisc™ System for transdermal delivery of liquid formulations of proteins, peptides and small molecules.  Unlike prefilled syringes, auto-injectors and pens that provide one delivery option (bolus), the Sofusa™ DoseDisc™ System is designed to provide drug developers a range of controlled delivery options without requiring reformulation.  Simple-to-administer and pain-free for patients, the Sofusa™ DoseDisc™ system has been approved by US FDA for two INDs.  A qualified supply chain is in place and scale-up of cGMP production is underway.  A successful Phase I clinical trial was completed in 2014.

Purpose of the Role:

Provide engineering and manufacturing operations leadership to support the delivery of $500MM net sales by 2020 and $2B by 2025 at targeted costs. Ensure FDA/Global regulatory approvals, and commercial supply of the Sofusa™ combination product for multiple drug candidates.

 

Role Accountabilities:

 

  • Deliver a Continuous Supply of Sofusa™ Combination Products
  • Lead the design, engineering, purchase, installation, start-up, and validation of all required manufacturing equipment with external CMOs.
  • Lead all operation responsibilities of the Sofusa™ supply chain including costs, quality, inventory, working capital, and safety.
  • Lead site operations at the Sandy Springs manufacturing facility.
  • Support all development, FDA approval, and commercial supply needs.
  • Lead all FDA/Global regulatory GMP documentation requirements for applications and audits.
  • Develop supply chain vendor options for multi-sourcing and supporting capital plans
  • Work with Procurement on all supply agreements.
  • Support FDA Audits.
  • Build Pathways for Commercialization
  • Evolve and build network of suppliers and CMO’s to ensure that Sofusa™ has access to capabilities necessary for success
  • Develop relationships with Pharma partners to support clinical trials and successful commercialization
  • Identify opportunities to streamline supply chain
  • Build Safety and FDA Compliance as a Core Culture
  • Execute LEAN and World Class Manufacturing Principles.
  • Business Priorities
  • Meet quality and safety specifications
  • Uninterrupted supply.
  • Achieve target costs
  • Successful Pharma partnerships
  • Contribute to the development of a winning culture in the Sofusa™ BU
  • Develop, implement and maintain capital budget and system for developing strategy
  • Develop strategy for equipment needs for startup and manufacturing of product

Ever wonder what it is like to belong to this global company? Here are some reasons to join us: http://bit.ly/WorkingatKC .  Interested in being a part of a new BU?  Sending your resume can jump-start our process to – Dorothy.Beach@KCC.com.

Qualifications:

  • Bachelor’s Degree with engineering discipline preferred.
  • 10+years experience in commercial production of FDA regulated combination products (Drug Delivery highly preferred).
  • 10+years experience in the design, engineering, start-up, and validation of commercial equipment used in the production of combination products.
  • Strong knowledge of all requirements and validation activities necessary for GMP manufacturing of a combination product.
  • Strong knowledge of manufacturing equipment procurement and capital strategy development and maintenance.
  • Proven ability to perform in cross-functional teams, manage global suppliers and lead contract manufactures (CMOs).
  • Experience in gaining the support and backing of senior leaders for capital strategies and investment plans.
  • Good communication skills to multiple audiences.

 

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 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.

Halyard Health hiring Compliance Audit Lead | GA

Halyard logo

Title:  Compliance Audit Leader (technical SME)

Company: Halyard Health/ formerly of Kimberly-Clark Corporation

Location: Alpharetta GA

Function: Quality Assurance, Regulatory & Compliance

Reports to: Director

Scope: Global – Manage a team of 5-10 reports (indirectly)

Halyard Health [NYSE: HYH] is a medical technology company focused on preventing infection, eliminating pain and speeding recovery for healthcare providers and their patients. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today’s most important healthcare needs, such as preventing healthcare-associated infections and reducing the use of narcotics while helping patients move from surgery to recovery. Halyard’s business segments — Surgical and Infection Prevention and Medical Devices — develop, manufacture and market clinically superior solutions that improve medical outcomes and business performance in more than 100 countries. For more information, visit http://www.halyardhealth.com. 

Role summary

Role will manage the overall Internal Manufacturing or Supplier Compliance Audit program across Halyard Health Inc., including but not limited to:

  • Manage and continuously improve the Internal Manufacturers or the Supplier Compliance audit process globally
  • Facilitate and provide guidance and direction related to compliance activities including alignment with new regulations
  • Coordinate cross-functional teams in the development and execution of compliance programs, evaluate facility audit programs and special technical gap assessments
  • Develop and maintain metrics associated with the Compliance program
  • Act as global Internal Manufacturer or Supplier QA Compliance SME
  • Assure the integrity and reliability of information systems and the Halyard Health Compliance Audit Schedule and risk assessment process, evaluate, approve and monitor corrective actions derived from the compliance audits
  • Coordinate as needs joint audits and special compliance gap assessments with other groups, facilitate FDA readiness training for internal manufacturers
  • Support FDA and external audit activities across Halyard locations;
  • Identify issues and drive internal manufacturing compliance improvements to ensure efficient regulatory compliance and reduced compliance risk and recommend compliance improvements needed with regular suppliers and contract manufacturers
  • Assess and qualify supplier and evaluate risk associate with transfer activities between internal manufacturers, new acquisitions and suppliers
  • Act as a SME coach to drive compliance activities across different locations

The incumbent will:

• Manage the Internal Manufacturing and/or the Supplier Compliance Audit program and compliance activities
• Facilitate multi-site and cross-functional review of compliance management system performance
• Manage the Halyard Compliance Audit Schedule and Risk Priority Matrix
• Coordinate annual compliance audit activities
• Ensure Compliance Management program meets regulatory requirements
• Assist in the development of computerized QS for Compliance Audit Management
• Develop and maintain Compliance Management procedures
• Develop and deploy meaningful compliance metrics
• Conduct evaluation of external regulatory trends and comparison with internal compliance results to determine actions needs in future compliance activities
• Develop and deliver training modules for Compliance Management
• Provide updates of Compliance Management activities to expedite innovation and risk mitigation in quality systems compliance
• Conduct compliance training activities with internal manufacturers as necessary
• Manage regulatory inspection audit database for internal facilities and oversee corrective actions submitted for external audits and inspections
• Maintain regulatory inspection database for notifications received from contract manufacturers and suppliers and evaluate potential risk for Halyard Health
• Act as Compliance advisor in critical/complex product and process system projects/
• Participate in FDA readiness activities and support FDA and External Audit process as necessary
• Participate in due diligence activities as required

Interested?  Please send your resume to d.beach@accenture.com to start our process. We can then have a chat in the next few business days to discuss your fit versus your career plans.

 Qualifications

  • B.S. in Engineering, Science, Quality Systems or related field
  • Certification as CBA, CQA or ISO 13485 Lead Auditor (strongly recommend or to be obtained during the first 3 months in the position)
    • 7-10 years of Manufacturing, Quality Engineering, Compliance, Quality Systems or Regulatory Affairs experience in medical devices, pharmaceutical, biologics, or other highly regulated industry
    • 5-7 years of experience conducting gap assessment, risk analysis of complex failure investigations,internal/supplier or external audits; quality system remediation projects or similar compliance activities in quality systems for medical devices (this can include QS Management experience on Quality operations, coordination of quality engineering or quality systems activities, customer complaint handling, risk assessment or design control activities, supplier quality, etc.)
    • Experience as an Internal Auditor, Lead Auditor, Project Management coordinator or conduction complex gap assessments of manufacturing process or product related issues.
    • General Knowledge of 21CFR requirements
    • Knowledge of ISO standards like ISO 13485, ISO 9001, ISO 14971
    • General understanding of Sterilization and Environmental standards
    • Strong project management and failure investigation/root cause analysis skills (highly desired)
    • Strong technical skills expertise (product validation, process, validation, software validation, reliability, risk assessment, statistical techniques) (Highly desired)
    • Proven record of successfully working in a global environment
    • Due to the high interaction with Internal Halyard locations or the regions, a fully bilingual (English/Spanish) person is required
    • Excellent written and verbal communication skills
    • Excellent instruction/teaching skills

    Specialized Knowledge:
    • Masters in Engineering, Sciences or Statistics (highly desired)
    • 10 years relevant work experience in medical devices, pharmaceutical or biologics industry
    • Knowledge in 21 CFR 801, 803, 806; Part 11, CFR 58 and other FDA requirements
    • Knowledge in other regulations like JPAL Min. Ordinance 169, CMDCAS, MDD, NIOSH, ANVISA, etc.
    • Experience in deploying QS in a global environment
    • Experience in Supplier Evaluation activities
    • Medical device GxP & ISO Standards proficiency
    • Supplier/process/system validations proficiency
    • Risk assessment, Hazard Analysis, FMEA, QFD proficiency
    • Problem analysis proficiency
    • Statistical proficiency
    • Strong interpersonal skills
    • Leadership skills

 

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.

Halyard Health 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.

Project Management Capability Leader | GA

 

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Title:     Project Management Capability Leader

Job #1300029G, Kimberly-Clark Corp.

Location: Roswell GA just north of Atlanta

Function: Strategy and Operations

Reports to: Director of Strategic Business, Healthcare

 

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!
Key Accountabilities:

• Serve as project/program leader for select business-critical portfolio projects/programs

 

• Develop and implement a standard project management methodology and associated tools across KCHC to continuously improve the sector’s  capabilities to execute the portfolio

 

• Develop and implement a project management certification process that delivers project management training and experiences to develop the business, technical, and management  skills required for project leaders to execute projects consistent with SEO standards

 

• Work collaboratively with all levels of the KCHC organization to support key project teams deliver expected business results

 

Key Competencies:

 

• Business Acumen– Understands business objectives, goals, and strategies

 

• Leadership – Ability to motivate, delegate, and empower

 

• Project Management– Effectively initiates, plans, executes, monitors, and closes complex projects

 

• Influencing – Ability to gain others’ support for ideas, proposals, projects, and solutions

 

• Change Management – Ability to drive the movement from current to improved state

 

• Relationships &Team Building – Builds and manages relationships across business functions

 

• Stakeholder Management – Effectively communicates with, negotiates with, and influences key stakeholders

Interested? You can contact Dorothy.Beach@KCC.com to receive more information on job #1300029G  .   Sending your resume can allow a more intelligent discussion between your career goals and what Kimberly-Clark needs.

Qualifications: 

•       Bachelor’s Degree

 

•       Project Management Certification or equivalent required

 

•       5-10 years of successfully managing high-profile business projects in the regulated environment with a  preference toward medical device industry

 

•       Successful track record of project management leading cross-functional teams to deliver medical device products from concept to commercialization

 

•       Experience with disciplined product development processes (stage/gate product development method)

 

•       Experience with successfully driving the implementation of a common project management methodology across an organization

 

•       LEAN and Continuous Improvement experience preferred

 

  • Willingness to travel 25% of the time

 

Kimberly-Clark seeking Manufacturing Quality Director, NA | WI

Kimberly-Clark seeking Manufacturing Quality Director, NA | WI

Title:  Quality Director, North American     

Job #17053

Location: Neenah WI (http://bit.ly/FoxCitiesVideo)

Function: Fem/Senior Marketing

Reports to: Product Supply Lead

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.

Summary of Position:

This position has responsibility for developing and implementing programs, capabilities and initiatives that create the overall quality and regulatory system for the North American AFC 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 AFC business.

Organization: People, Responsibilities, reporting and Partnerships:

•           Direct reports: TBD (anticipated 10 exempt; 1 non-exempt)

•           Key relationships include North American AFC Product Supply leader, senior AFC R&E leaders, brand champions, consumer services, material suppliers, procurement, third party manufacturers, plant operations (consumer and health care), corporate quality, corporate communications, legal and FDA.

Key Responsibilities:

•           Provide expert leadership and consultation to senior AFC 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 AFC to meet business objectives and innovate in the marketplace at targeted speed to market.

•           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 AFC 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

•           Develop and deliver training to plant and staff that focuses on optimization of quality and regulatory systems and practices. 

•           Represent AFC for quality and regulatory matters both internally and externally, including a strong and active partnership with the FDA.

Interested? Or perhaps you know of someone that might be, you can apply directly using this link: https://bitly.com/17053-QualSupp   and it will be reviewed within several business days 

Basic Qualifications

•           Position requires an undergraduate degree.

•           More than fifteen years of quality and regulatory-related experience

•           Experience in FDA-regulated personal care consumer products manufacturing operating in both a plant and corporate environment

•           Ability to travel by ground and air up to 50% of the time.

Preferred Qualification:

•           MBA or MS as well as certain industry and ISO certifications

•           Experience with Lean / Continuous Improvement tools and methodologies and third party manufacturing. 

•           Demonstrated experience interacting with FDA and leading in an environment subject to FDA-regulated governance

US FDA approves new K-C Health Care child’s face mask

K-C partners with the Food and Drug Administration to fill a clinical gap.

Kid’s share everything. Most of the time, this behavior is encouraged in younger generations except when it’s germs that are being shared. K-C Health Care was sought out by the leading associations in the healthcare industry and worked with the US Food and Drug Administration to create a product to help control germ sharing among little ones.

During the H1N1 flu pandemic, increased demand for face masks including those to protect children, brought heightened awareness to current offerings in the marketplace.   The Food and Drug Administration had not   established guidelines for a pediatric mask, such as who should wear them or when they should be used.

The Society for Healthcare Epidemiology of America, Association of periOperative Nurses and the Association for Professionals in Infection Control and Epidemiology formally requested that K-C and other mask suppliers apply for Food and Drug Administration clearance for pediatric face masks. K-C and these interested organizations helped define key considerations that shaped the face mask design and recommended ages for use. K-C Health Care worked with the Food and Drug Administration to develop standardized clinical measurements that are specific to the unique circumstances of pediatric mask use and performance in healthcare settings.

K-C Health Care is partnering with Disney to cover the little masks with colorful and familiar characters. Decorating the masks with Disney’s cheerful crew will help children feel more comfortable in what can be a stressful situation – visiting the doctor.

The K-C Health Care child’s face mask is a single-use device that is designed for children ages 5-12 to provide protection for the respiratory tract. The face mask has been specifically designed to fit small faces to maximize effectiveness and comfort.

The face mask is intended for use in healthcare settings such as waiting areas and exam rooms to protect children who may be at increased risk for infection. These include children who are already ill, immuno-compromised, displaying flu-like symptoms, potentially contagious while visiting a patient family member or having a routine check-up during flu season or a pandemic outbreak.  According to the Centers for Disease Control and Prevention, even patients with undiagnosed respiratory symptoms should be asked to wear a face mask in the waiting room.

“Children are among our most vulnerable patients. Designing products that fit their bodies and make them feel as comfortable as possible can significantly support all our efforts to reduce the spread of infection,” says Jay Hexamer, general manager for North America Medical Supplies, K-C Health Care.

“K-C Health Care is proud to have received this landmark regulatory clearance for our pediatric face mask, and greatly appreciates the important input and guidance we have received from our customers, the clinical community and the Food and Drug Administration.

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.