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Manager, Quality Assurance
A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 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.
As the QA Manager, Quality Improvement with MilliporeSigma, you will have responsibility for driving continuous quality improvement initiatives across our testing facilities in Rockville, MD and our global testing sites. The QA Manager provides leadership and expertise on quality management processes, data analysis & tools, and quality improvement. You will lead a team of experienced Quality professionals and will report to the Head of Quality.
- Manage team of QA personnel and/or supervisors to ensure performance and resource utilization requirements are met
- Responsible for setting strategy direction for the Quality Improvement team
- Ensure proper oversight and management of Quality Management System (TrackWise) for timely response & actions
- Build and implement robust Quality Risk Management (QRM) program and use to drive quality improvement
- Responsible for developing and reporting quality KPIs to site/global leadership
- Work directly with internal and external customers to assure Best-in-Class expectations for quality are met or exceeded
- Analyze trends, quality metrics and other data to identify quality and compliance gaps
- Communicate quality and compliance gaps to senior leadership and drive improvements within cross-functional departments
Who You Are:
- Bachelor’s degree in a scientific (i.e., Biology, Chemistry, etc.) or technical (i.e., Biotechnology) field
- 6+ years of experience in Quality Assurance within an FDA and/or EU regulated environment (cGMP, GLP, Data Integrity)
- 3+ years of management experience
- Proven results using quality improvement tools and techniques including Lean Six Sigma methodologies to drive improvements across global sites
- Previous experience with ICH Q9 guidance and managing mature Quality Risk Management program
- CRO, CMO, or CDMO experience in regulated environment (e.g., US FDA, EMA)
- Collaborative approach and ability to build strong partnerships with local and global cross-functional teams to drive results
- Demonstrate excellent communication, facilitation, and conflict resolution skills
- Certification in quality engineering, quality improvement, and/or six sigma
- Project Management experience and/or certification
- Previous experience mentoring and coaching experienced Quality professionals
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.