Amgen
biotechnology
QAManager,ExternalSupplyQuality
“QA Manager, External Supply Quality at Amgen. Skills: Quality Management, Supplier Quality, Regulatory Compliance. Drive proactive quality management of suppliers. Act as the quality lead for supplier relationships”
What You'll Achieve.
ensure reliable and quality supply of our products; ensuring compliance with global GMP standards and Amgen’s high expectations; ensuring performance through robust monitoring, technical site visits, and continuous improvement; Support management of audit/inspection commitments to completion
Industry & Context.
Skilled in using risk based decision-making approaches
Requires occasional travel to contract manufacturing locations located in China, Japan, Singapore, and India., Candidates located in other JAPAC regions may be considered based on qualifications., Role will require occasional travel and onsite engagement with contract manufacturing sites., Fulfilling the medical requirements of this job scope.
What They're Looking For.
Must Have
Quality and/or Manufacturing experience at small and/or large molecule drug substance or drug product manufacturing facilities, Experience with analytical testing situations (e. g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing), Confident communicator who can build relationships across technical and cultural boundaries, Track record of driving change, improving systems, and mentoring/coaching others, Skilled in using risk based decision-making approaches, Experience with regulatory activities and variation management
Nice to Have
Technical experience with synthetics/small molecules a plus
What You'll Do.
Drive proactive quality management of suppliers
Act as the quality lead for supplier relationships
Review and approve quality documentation
Provide quality oversight and approval steps for new product introductions
Perform tactical batch disposition activities
Negotiate Quality Agreement terms and conditions
Perform supplier audits
Act as a key quality partner to manufacturing
Take the lead in cross-functional initiatives
Ensure inspection readiness for contract manufacturing sites
Represent Amgen at product-specific regulatory inspections
Perform person in plant responsibilities
How You'll Work.
Team & Collaboration
Act as a key quality partner to manufacturing, supply chain, process development, and other Amgen internal functions.
Communication Scope
Confident communicator who can build relationships across technical and cultural boundaries
Process & Methodology
Take the lead in cross-functional initiatives and continuous improvement projects
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