CMO QA Manager - Biologicals
The European head office (WEU) is based in Hoofddorp, The Netherlands
The CMO QA Manager is responsible for managing quality aspects at external Contract Manufacturing Organizations for Sun Pharma Products for the EU market. Ensure that the operational business at Contract Manufacturing Organizations is in compliance with Current Good Manufacturing Practice, with the Quality Assurance Agreement, regulatory requirements and the Sun Pharma Standards. Ensure that activities at Contract Manufacturing Organizations are conducted according to the relevant Standard Operating Procedures. Active participation in Product Acquisitions and technology transfer X functional projects.
• Bachelor degree or higher in Pharmacy, Biology, Biochemistry, Virology, Microbiology or another related science.
• 8 or more years’ experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products.
• Experience in Quality Assurance Operations, production, Quality Control and/or other relevant operational areas, but must include minimally 5 years in Quality Assurance, and 3 years of management and or project management experience. Experience in combination products is a plus. Experience as QP is an asset.
• Thorough knowledge of Current Good Manufacturing Practice requirements.
• Strong understanding of regulatory requirements for commercial products.
• Proven track record with Food & Drug Administration, European Medicines Evaluation Agency and other Health Authorities.
• Strong understanding of risk assessment and risk management fundamentals/tools.
• Strong Technical understanding of (bio) pharmaceutical processes.
• Ability to effectively manage multiple, complex priorities.
• Team and consensus builder, with definitive and authoritative decision making ability.
• Fluent in speaking / writing in English.
Terms of employment
Email : firstname.lastname@example.org
Telephone : +31 (0) 623 135 118