External Quality Assurance Manager (m/f)

REFERENZNUMMER:

362602/11

IHRE AUFGABEN:

-Represent the IMP External Quality function on Technical Development Teams, as needed, to include Contract Development Manufacturing Organizations (CDMO) Quality Systems assessments, assuring CDMO (c)GMP compliance, and tracking appropriate metrics
-Responsible for review of Master Batch Records, executed Batch Records and any associated deviations and investigations
-Prepare Quality Agreements and corresponding Product Specific Requirements
-Negotiate and maintain Quality Agreements with selected CDMOs and ensure the requirements of the Quality Agreement are fulfilled (in collaboration with other quality functions)
-Provide technical subject matter expertise and guidance by supporting or managing deviations and investigations, changes, specifications and regulatory submissions
-Participate in due diligence visits and compliance audits to assess CDMO Quality Systems for development and processing of investigational medicinal products
-Build strong relationships with both internal operations units and external CDMOs
-Provide equipment/facility qualification and process validation support to Small Molecule programs
-Perform quality risk assessments, develop mitigation plan and follow-up on implementation
-Provide input in the design of sampling plans and product specifications for intermediates, API and drug product

IHRE QUALIFIKATIONEN:

-MS/PhD in life sciences or equivalent
-Profound experience in pharmaceutical manufacturing, quality assurance and/or quality control
-Project experience in a quality role and in operating quality systems in pharmaceutical operations
-Demonstrated proficiency in interpretations of (c)GMP regulations
-Proficiency in German and English

WEITERE QUALIFIKATIONEN:

Quality manager