Manager

• Provide biomarker quality leadership and oversight across GxP-related research, development, clinical trials, and potential commercialization into IVDs
• Collaborate with business partners and GCP Operational Quality to drive quality outcomes and operational excellence
• Support operational management oversight, audit strategy, regulatory document reviews (BBs, INDs, IDEs, TMFs)
• Develop scope for GCLP and GCP biomarker vendor audits and participate in vendor quality engagement
• Contribute to inspection readiness, design of quality metrics, governance meetings, and due diligence/integration activities

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