Senior Manager Quality Assurance – Major Deviations Lifecycle

About the role

Amgen is seeking a Senior Manager to lead the Major Deviations Lifecycle Team. In this strategic position you will oversee the investigation, root‑cause analysis, risk assessment and closure of significant quality events across manufacturing, packaging, laboratory and support operations, ensuring product quality and patient safety.

Key responsibilities

• Lead and develop the Major Deviations Team, managing performance, coaching and resource planning.
• Provide scientific, technical and regulatory oversight for complex deviation investigations.
• Ensure deviations are initiated, investigated, approved and closed within defined timelines and procedures.
• Drive robust root‑cause analyses using structured methodologies and risk‑based decision making.
• Maintain accurate documentation in the digital quality management system (DQMS) and oversee effective CAPA implementation.
• Collaborate cross‑functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs, Process Development, EHS and Validation to ensure inspection readiness and continuous improvement.

Required profile

• Extensive experience in quality assurance within biopharmaceutical manufacturing.
• Proven leadership and people‑management capabilities.
• Deep knowledge of deviation investigations, root‑cause analysis, risk assessment and CAPA processes.
• Strong understanding of regulatory requirements and inspection readiness.
• Ability to translate business priorities into operational objectives.

Required skills

What we offer

• Opportunity to impact patient lives through high‑impact quality leadership.
• Collaborative, innovative and science‑driven culture.
• Career growth within a global biopharma leader.