King of Prussia, PA
Director of Quality Assurance
Director of Quality Assurance
FPC of Atlanta
FPC of Atlanta
Reporting to the Vice President of Quality, as Director Quality Assurance and most senior QA professional on-site for this well positioned pharmaceutical CDMO you will:
• Lead the Operation and Management of Quality Assurance.
• Lead the Development and Maintenance of the Quality Management System.
• Serve as part of the Site Leadership Team.
• Key member of Global Pharma Services Senior Management Team.
• Maintain QA oversite of the Quality Control Laboratory.
• Represent the Quality Unit to Regulatory Authorities and Customer & External Audits.
• Inform upper-level management if quality standards appear to fall short of GMPs.
• Manage Technical and Quality Agreements with clients and 3rd party service providers.
• Provide input to Training Department from a Quality and GMP perspective.
• Lead the Development and Maintenance of the Quality Management System.
• Serve as part of the Site Leadership Team.
• Key member of Global Pharma Services Senior Management Team.
• Maintain QA oversite of the Quality Control Laboratory.
• Represent the Quality Unit to Regulatory Authorities and Customer & External Audits.
• Inform upper-level management if quality standards appear to fall short of GMPs.
• Manage Technical and Quality Agreements with clients and 3rd party service providers.
• Provide input to Training Department from a Quality and GMP perspective.
As the ideal candidate you will possess experience that includes:
• At least 10 years’ Quality and Quality Personnel Leadership.
• Lead role in Regulatory Inspection and other Customer or External Audits.
• Commercial Manufacturing or Packaging of Pharmaceuticals.
• Employment with a CMO / CDMO.
• Large or Medium Pharma experience highly desirable.
• Secondary Packaging.
• Strong Leadership, a pragmatic approach to quality and a collaborative approach to decision making.
• Lead role in Regulatory Inspection and other Customer or External Audits.
• Commercial Manufacturing or Packaging of Pharmaceuticals.
• Employment with a CMO / CDMO.
• Large or Medium Pharma experience highly desirable.
• Secondary Packaging.
• Strong Leadership, a pragmatic approach to quality and a collaborative approach to decision making.
This is a highly visible and impactful position in a company that appreciates and recognizes contributions, provides competitive compensation & benefits and relocation support.
Compensation includes Salary, Bonus & LTI.