Senior Manager Corporate Quality Compliance
Amgen Inc
Amgen seeks a Senior Manager for Global Quality Compliance to lead audit execution, compliance assessments, and regulatory alignment across manufacturing sites, contract facilities, and suppliers. The role requires managing quality risks, supporting regulatory inspections, and directing cross-functional compliance initiatives.
Responsibilities
- Coordinate and lead Global Quality Compliance audits of corporate sites, contract facilities, affiliates, and suppliers
- Assess compliance status, participate in deficiency corrections, and alert executive leadership to significant risks
- Serve as subject matter expert on regulated requirements and support regulatory authority inspections
- Own QA approval for quality event records including deviations, CAPAs, and change controls
- Lead cross-functional teams and ensure alignment of Amgen standards with regulatory expectations
Requirements
- Bachelor's degree and 8 years of auditing experience, or equivalent combination of education and experience
- Minimum 2 years of direct people management or team leadership experience
- Certified Quality Auditor (CQA) or equivalent certification
- Experience with aseptic processing, drug product/substance, combination products, and data integrity
- Ability to travel domestically and internationally approximately 50%
- Knowledge of international regulations and standards preferred
Vacancy posted 10 days ago
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