Quality Management Systems Specialist

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

The Quality Management System (QMS) Specialist role involves overseeing the Quality Assurance (QA) program and quality systems at the site level. This includes maintaining oversight of the QA program from a QMS perspective, running weekly CAPA Review Board (CRB) and Quality Review Board (QRB) meetings, developing high-level dashboards, preparing periodic reviews of the quality system, collaborating with cross-functional teams, writing, reviewing, and approving Deviations, CAPAs, Complaints, and Change Controls, leading cross-functional teams, developing, and executing remediation plans, and maintaining quality system KPIs. This role requires a strong background in quality assurance and compliance, with a focus on sterile manufacturing environments and a proven ability to lead compliance remediation projects, manage timelines, and communicate complex compliance concepts effectively.

Minimum Qualifications:

• Associate's Degree in Microbiology, Biology, Medical Technology, Pharmacy, Biochemistry, Engineering, or other life science discipline with 5+ years of experience in Quality Assurance and/or compliance roles within the pharmaceutical or biotechnology industry

OR

• Bachelor's Degree in Microbiology, Biology, Medical Technology, Pharmacy, Biochemistry, Engineering, or other life science discipline with 3+ years of experience in Quality Assurance and/or compliance roles within the pharmaceutical or biotechnology industry

Preferred Qualifications:

• Strong focus on sterile manufacturing environments
• In-depth understanding cGMP, Data Integrity, and Quality Systems
• Proven track record of successfully leading and managing compliance remediation projects, ideally within sterile manufacturing facilities
• Strong project management skills
• Excellent communication skills
• Experience collaborating with regulatory agencies and conducting audits or inspections

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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

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