Quality Assurance Compliance Manager

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 Assurance Compliance Manager is responsible for effectively managing all Quality Assurance aspects of the Quality Management System (QMS) to ensure that process and procedures are in compliance with cGMP and other regulations and standards as appropriate for Active Pharmaceutical ingredient (API) manufacture.  Reporting to the Site Head of Quality and in partnership with the QA Operations Leader and QA Customer Leader, the Quality Assurance Compliance Manager creates a positive image of Millipore Sigma through communication and interaction with key stakeholders including employees, customers, LS quality organization and business partners, vendors, and appropriate governmental and regulatory authorities.

The Quality Assurance Compliance Manager provides leadership and expertise on quality compliance processes and tools.  You will lead a team that manages specific quality management systems and processes such as deviation management, CAPA management, Change Control, Risk management, Data integrity, Quality Management and Annual Product Reviews, Supplier quality Management, Quality agreements, Training, Field corrective actions, Management of regulatory and customer audits, complaint management and divisional policy implementation. Responsible in collaboration with the site personnel for ensuring that the site is in a state of continuous inspection readiness.

Roles and responsibility 

The Quality Assurance Compliance Manager possesses detailed knowledge of cGMP. Highly developed interpersonal, written and verbal skills, including the ability to influence and drive improvement to Madison/Verona quality management system.  They must be able to establish strong collaborative relationship with all departments within the organization to deliver on quality and regulatory commitments and have the ability to work autonomously, effectively manage time and deliver results on time.

Minumum Qualifications:

• Lead and develop a team of qualified professionals to manage all Quality Assurance aspects of the Quality Management System (QMS) to ensure that process and procedures are in compliance with cGMP for API manufacture in a Contract manufacture organization
• Maintain and communicate a clear quality vision for the safe, efficient and compliant production of APIs and other GMP compounds

Preferred Qualifications:

• Develop and implement programs to establish and maintain quality standards of existing products, as well as developing programs to focus employees on quality improvement.
• Ensures the organization has an ‘Inspection Ready’ program with personnel preparation for hosting inspections and inspection follow up.
• Owner of the Sites Quality and Regulatory Heat Map with responsibility to drive the risk reduction programs and support the initiation and review of quality improvement plans.        
• Provide GMP training and governance to the site and responsible for the site training program as executed in the Learning management system (LMS).      

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