A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Head of Quality is a key member of the site Leadership Team and reports to the Site Head (Head of West Coast Biologics). In this role you will be a critical leader of a significant Quality function and will drive improvement activities including the maintenance of comprehensive quality metrics. Position will partner with the manufacturing organization and support teams to make recommendations, set goals, and implement solutions for process improvements. Another key component of your role will be leveraging your ability to effectively lead a team of approximately 20 people and facilitate the learning and development opportunities for our QA/QC teams and the greater organization.
- Manages and coordinates all Quality Assurance and Quality related activities at the Millipore Sigma Rocklin, California site
- Ensures compliance of QMS with regulations, IS13485 & FDA and global medical device regulations.
- Develops and implements programs to establish and maintain quality standards of existing products, as well as developing programs to focus employees on quality improvement. Implements policies, procedures and methods to check product, material, components and/or operational quality and improve same.
- Provides Quality leadership and direction to support business operations and develop of the site quality strategy.
- Provides focus on the quality status and performance of the Operations site by instilling a culture of quality and continuous improvement
- Assures the implementation and alignment of the LS Quality Management System and compliance to the pertinent global regulations.
- Responsible for day-to-day management, setting objectives, coaching and developing employees, performance appraisal, determining employee compensation.
- Defines team organization, roles and responsibilities and is financially accountable to attain budgets.
- Drives important negotiations and influences stakeholders internally and support interaction with strategic customers for quality requirements, incident handling and quality performance, and support interaction with authorities by the regulatory management
- Approve signatory for major changes and NPI gate reviews.
- Management representative for compliance to IS13485
- Lead and manage critical quality incidents, interact with authorities with the support of the regulatory team and supports the Quality Operations cluster.
- Perform gap assessments and lead the site implementation of corporate Quality policies.
- Participate in the recruitment and development of QA/QC staff, ensuring all team members have appropriate goals and objectives set.
- Actively manage the performance and development of teams using available tools and procedures.
- Actively promote and demonstrate adherence to Health and Safety policies and practices, acting as a role model for other employees within the organization.
Who You Are:
- BS degree, graduate degree (e.g. Biologist, chemist, microbiologist, quality engineering) preferred
- 10+ years of hands-on experience in Quality with managerial experience
- Demonstrated subject matter expertise and knowledge of theories, principles and concepts within QMS
- A minimum of 8 years at a senior level (manager or higher) leading a QA/QC groups in a life science, GMP/FDA regulated industry. Medical device or Life Sciences experience is preferred
- Proven experience developing teams
- Experience with common continuous improvement tools (e.g., Six Sigma)
- Knowledge of Quality Risk Management
- Experience leading regulatory inspections and audits
- Extensive knowledge of EU/US GMP regulations and related standards
- Excellent written and verbal communication/ presentation skills and organizational skills
- Logical in thought and detail focused
- Proven ability to lead change through an organization
- Analytical approach to problem solving and decision making
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.