Cmc Global Product Quality Manager

Harry Walsh Associates Ltd

Cork, Dublin North

We are currently recruiting a CMC Global Product Quality Manager who will be responsibile forquality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced bycompanyplants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Experience: Bachelor’s Degree in relevant Life Science or other technical discipline or equivalent job experience required. 8+ years of total combined experience. At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development, Regulatory or Consulting. Direct Plant experience in a Pharmaceutical setting is beneficial. Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients. Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required. Experience with FDA and other regulatory agency interactions and inspections. Familiarity with the requirements for third party external manufacturing. This job originally appeared on RecruitIreland.com.

2247 days ago