Senior Manager, In-Vitro Diagnostics/Precision Medicine Quality
Amgen Inc
Senior Manager role overseeing quality strategy for in-vitro diagnostics and companion diagnostics in Amgen's precision medicine clinical trials. Reports to the Director of Precision Medicine and Diagnostics Quality within R&D, supporting regulatory compliance and risk-based quality oversight across global diagnostic partnerships and testing laboratories.
Responsibilities
- Provide quality oversight and subject matter expertise for IVD medical devices used in precision medicine clinical trials
- Support clinical trial inspections from health authorities, including readiness preparation and findings management
- Collaborate with IVD and diagnostic partners to ensure quality oversight and regulatory compliance
- Maintain current knowledge of evolving IVD regulations; communicate regulatory impacts to business stakeholders
- Provide quality assurance through auditing, deviation management, and inspection management for IVD activities
Requirements
- Doctorate degree with 2+ years quality/regulatory/CDx experience, or Master's with 4+ years, or Bachelor's with 6+ years, or Associate's with 10+ years, or high school diploma with 12+ years
- Experience with in-vitro diagnostics and companion diagnostics in pharma/biotech or medical device industries
- Knowledge of IVD medical device development and global regulations including EU IVDR and FDA CDx Final Rule
- Quality management system experience including deviation management, CAPA, audits, and inspection support
- Familiarity with precision medicine regulatory landscape and quality management systems (QMS)
- Experience with GxP compliance and third-party vendor oversight
Vacancy posted 15 days ago
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