Manager QA
Amgen · Breda, Netherlands
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Role summary
Amgen seeks a Manager QA for its Breda manufacturing facility to lead quality assurance staff, oversee compliance with pharmaceutical standards, and manage shift operations. The role involves performance management, cGMP documentation review, regulatory liaison, and continuous improvement initiatives supporting medicine labeling, assembly, and distribution.
What they're looking for
- Master's degree in Pharmacy or equivalent, or other Master's with relevant pharmaceutical GMP experience
- Two or more years of professional experience in clinical/commercial manufacturing, GMP, warehousing, or supply chain
- Knowledge of equipment engineering principles, validation, and batch review processes
- Scientific problem-solving abilities and risk-based decision-making skills
- Strong written and verbal communication and technical presentation capabilities
- Optional: Qualified Person certification per EU directive 2001/83/EC article 49
What you'll be doing
- Lead and manage Quality staff performance, development, and shift roster planning
- Oversee cGMP record review and approval including deviations, CAPAs, batch records, and change controls
- Provide real-time QA oversight and support for production operations and compliance guidance
- Lead quality investigations, participate in internal audits and regulatory inspections
- Drive continuous improvement and Lean Transformation initiatives to reduce repeating quality events
Privacy & handoff
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