Quality Assurance Manager (Gmp)

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:

MilliporeSigma in Miamisburg, OH is seeking a Quality Assurance Manager. As a Quality Assurance Manager, you will ensure that the Quality Assurance aspects of the Quality Management System (QMS) processes and procedures follow ISO 9001, ICH Q7, site and company policies.

Responsibilities:

• Provide leadership and expertise on Quality Assurance processes and tools
• Lead a team that manage specific quality management systems and processes such as Deviation, CAPA, Change Control, Training, Audits, Complaint Management, Supplier Quality, Document Control, Validation, and Data Integrity
• Ensure that departments responsible for products meet quality standards and performance goals of MilliporeSigma
• Ensure that all aspects of GMP product release meet analytical, production, packaging and labeling specifications in accordance with established quality systems
• Support the site’s compliance activities through accurate regulatory recordkeeping and reporting
• Manage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001 and cGMP
• Hire, train and develop qualified staff to ensure effective execution of Quality Assurance tasks and attain operational and development goals
• Drive achievement of site vision and goals / objectives
• Drive risk reduction programs and ensure application of risk management and sound root cause analysis
• Analyze and report quality measures, performance, tends and improvements
• Review and approve quality documentation such as procedures, deviation, CAPA plans, OOS investigations, risk assessments and change controls to ensure compliance
• Provide Quality Assurance support to other site departments
Support the site’s regulatory activities representing the department during inspections by regulatory agencies such as DEA, FDA, etc.

Who You Are:

Minimum Qualifications :

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or other Science field
• 3+ years of experience with ISO 9001 and GMP requirements in the Chemical, Specialty Chemical and/or Pharmaceutical Industry
2+ years of experience in a leadership position

Preferred Qualifications:

• 5+ years of experience with ISO 9001 and GMP requirements in the Chemical, Specialty Chemical and/or Pharmaceutical Industry
• 3+ years of experience with progressing increasing responsibilities as a supervisor
• Experience with quality management systems such as Trackwise, electronic document management system, etc.
Experience with customer audits and regulatory 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