Manager, Quality Control – Analytical Testing

About the role

Amgen is seeking a Manager of Quality Control to lead analytical testing activities across raw material, utility, in‑process, release, and stability testing. The role ensures compliance with cGMP and regulatory standards while supporting both biologics and small‑molecule manufacturing.

Key responsibilities

• Lead day‑to‑day analytical testing operations, ensuring timely execution of schedules.
• Manage laboratory resources, staffing, workload prioritization, and capacity planning.
• Provide technical oversight for analytical methodologies and maintain equipment qualification, calibration, and compliance.
• Review and approve analytical records, investigations, deviations, CAPAs, change controls, and other quality documentation.
• Maintain inspection readiness and support regulatory audits, inspections, and quality assessments.
• Drive quality risk management, continuous improvement initiatives, and represent the quality unit during audits.
• Lead, coach, and develop a team of analysts, establishing performance expectations and development plans.
• Oversee method validation, transfer, verification, and lifecycle management activities.

Required profile

• Proven experience in analytical testing within a cGMP environment.
• Strong leadership and people‑management skills.
• Ability to prioritize work, manage resources, and ensure compliance.
• Excellent problem‑solving and decision‑making capabilities.

Required skills

• Analytical chemistry
• Bioassay
• Immunoassay
• Method validation
• Method transfer
• Method verification
• Lifecycle management of analytical methods
• cGMP compliance
• Data integrity principles
• Equipment qualification and calibration
• CAPA management
• Change control
• OOS/OOT investigation