Associate Director Plant Quality Assurance
Associate Director QA role at Amgen
The Associate Director QA is a senior leadership role within Quality responsible for oversight of production operations and developing, implementing, and overseeing compliance programs and continuous improvement initiatives. The Associate Director will lead and direct Quality staff, act as a Subject Matter Expert in their area, and partner cross-functionally to embed a culture of quality, drive operational excellence, and support organizational growth.
Responsibilities
Lead and direct Quality staff, managing performance and supporting development of technical and decision-making skills.
Provide QA oversight and support for production operations, including formulation, vial and syringe fill finish aseptic operations, and inspection operations.
Collaborate with Operations & Engineering to resolve quality and compliance issues, including Change Controls, Deviations, and CAPAs.
Represent Quality during audits and inspections.
Support Lean Transformation and Operational Excellence initiatives.
Basic Qualifications
University degree in Engineering or Science related discipline.
10+ years of experience in pharmaceutical or biotechnology industry, with a minimum 3+ years in a leadership role, or an equivalent combination of experience and education.
Technical skills and demonstrated competencies across a broad range of quality related disciplines.
Experience working with dynamic cross-functional teams and proven decision-making abilities.
Preferred Qualifications
Experience in aseptic operations, protein formulation, vial and syringe filling.
Knowledge of applicable regulatory requirements and experience with regulatory inspections.
Excellent written and verbal communication skills.
Seniority Level
Not Applicable
Employment Type
Full-time
Job Function
Quality Assurance
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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