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Vice President of Quality Assurance
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- Reporting to the COO, The Vice President, GxP Quality Assurance is responsible for establishing and leading Aveo's Quality Management System (QMS) operations and ensuring compliance with Local, State, Federal, and International regulations and standards associated with GXPs and Quality Systems in a fast-paced, primarily virtual development environment.
- The incumbent will lead the quality and related compliance activities for Aveo's commercial product (s) and pipeline candidates (ranging from early to late-stage clinical trials).
- The VP QA will direct all GxP Quality activities and ensures Aveo and its vendors are inspection ready, adhere to GLP, GCP, GPV, GDP and GMP applicable regulations, company policies & procedures.
- Lead and manage commercial QA oversight program including manufacturing, packaging and labeling, serialization, direct to practitioner sample program, third party logistics activities, to ensure compliance with DCSCA and associated regulatory requirements.
- Oversight and review of partnerships/relationships with CDMO/CMO/CTL/CROs and where appropriate, manage these relationships through quality agreements
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