Quality Assurance Compliance Manager at Millipore Corporation in Madison, Wisconsin

Job Description:

Work Location: Madison, Wisconsin
Shift: No
Department: LS-SC-POWQD Madison & Verona QA Group 3
Recruiter: Paul Therrien



This information is for internals only. Please do not share outside of the organization.




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).

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. Apply Now