Senior Manager Corporate Quality Compliance

Role: Senior Manager of Global Quality Compliance at Amgen, overseeing compliance audits and inspection readiness across corporate, site, and partner facilities within biopharma regulatory frameworks. Responsibilities include leading or supporting audits of Quality Management Systems, evaluating compliance risks, preparing audit plans, assessing regulatory adherence, and supporting regulatory inspections. The role involves providing expert guidance on global regulatory requirements, leading cross-functional teams, and supporting continuous improvement initiatives. Requirements: Doctorate with 2+ years or equivalent experience in auditing or quality assurance; certified Quality Auditor (CQA) preferred; 50% travel domestically and internationally. High-Value: experience with aseptic processing, drug substances/products, data integrity, and regulatory inspections; familiarity with international standards. Preferred: auditing in internal, CMO, or logistics settings; certification; strong organizational skills. The position may involve managing teams or projects and requires deep knowledge of GxP, regulatory compliance, and audit processes within biotech and pharma manufacturing environments.