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 will play a key role in the oversight of the Quality Assurance (QA) program and quality systems at the site level to support on time closures and overall QMS health.

• Maintain oversight of the QA program from a QMS perspective by driving on time closures and providing support for all records to ensure all systems remain compliant
• Assist with running weekly CAPA Review Board (CRB) to vet all CAPA proposals, communicate weekly and monthly forecasts and communicate any escalations
• Assist with running weekly Quality Review Board (QRB) to cover all QMS records, holistically. With emphasis on any Deviations or Complaints that are deemed to be Critical
• Develop and maintain high level dashboards for CAPAs, Deviations, Complaints and Change Controls based off of site KPIs
• Prepare periodic review of the quality system for quarterly Quality Management Review
• Strong collaboration, including problem solving and continuous improvement efforts, and communication with cross functional teams
• Write, review and approve Deviations, CAPAs, Complaints and Change Controls, as required
• Lead and inspire cross-functional teams, driving a culture of compliance and continuous improvement
• Development and execution of comprehensive remediation plans to address any gaps in the quality system
• Work with cross-functional teams to implement compliance improvements
• Maintain quality system KPIs
• Other responsibilities as required

Who You Are:

Minimim 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 Qualitfications:

• 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, including the ability to prioritize tasks, manage timelines, and allocate resources effectively
• Excellent communication skills, both written and verbal, with the ability to convey complex compliance concepts to a range of audiences
• 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