Global Product Quality Manager
- Maintains the primary quality lead with management oversight for project quality activities.
- Leads the development of global QA strategy to support pharmaceuticals, biologics, and devices produced on site and through TPM facilities.
- Makes key decisions on product quality and compliance and regulatory conformance issues.
- Establishes and maintains relationships with TPMs, on site plants, affiliates and other functional groups to maintain roles and responsibilities.
- Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality.
- Liaise with Quality Assurance audit team to develop audit and inspection readiness plans.
- Manages Quality Assurance elements needed to facilitate new product launches. Drives implementation of the Product Transfer Process from R&D to sites.
- Develops product quality transfer process monitoring metrics
- Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.
- Work with Affiliates and Regulatory to prepare submissions.
Education & Experience:
- Bachelor’s Degree in relevant Life Science or other technical discipline or equivalent job experience required.
- Minimum of 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 a requirement.
- Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, devices, OSD, capsules, XL, and/or APIs).
- 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.
- Ability to travel (25%).
If you would like to apply for this exciting Senior Global role in one of the world's largest pharmaceutical/biopharma companies and you meet the criteria above contact Clara Henry on 01 4744676 for a confidential discussion or click APPLY.