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
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.
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.
- 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.
- 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.