Senior Manager, Quality
Key Responsibilities:
* Be an integral quality member of Amgen cross-functional contract manufacturing team that includes business operations, analytical science, process development, supply chain, etc.
* Lead the representation, communication and management of quality issues with internal partners and external partners
* Serve as the main Quality point of contact and approver for deviations, change controls, CAPAs, and batch disposition etc. related to Amgen product
Quality Oversight and Compliance:
* Provide quality oversight of the manufacturing, testing, and release of Amgen products at CMOs
* QA review of all documentation associated with batch release to ensure GMP compliance
* QP Certification in compliance with marketing authorisations, of products manufactured at Amgen CMOs
Regulatory and Quality Agreements:
* Negotiator, author and Approver of quality agreements
* Lead the preparation of the site for and Represent Amgen at product-specific Regulatory Inspections and/or during Notified Body audits of CMO Site, as applicable or required
Skills and Qualifications:
* 10 + years biotech or pharmaceutical industry experience
* Qualified Person status is essential
* Additional European Languages - desirable not essential
* Significant Quality experience at Aseptic Manufacturing facilities