Clinical QA Manager

Marin Metro Area, CA

Job Type: Clinical Job Number: JN -032024-32270 Region: Marin Metro Area

Job Description

Our Bay Area client is recruiting for a Clinical QA Manager to join their growing team.

  • Provide quality oversight for internally manufactured early-stage products and starting materials
  • Provide support for audits and inspections of CDMOs and internal manufacturing and testing organizations
  • Provide quality oversight to release clinical phase 1 and 2 materials ensuring compliance with phase appropriate lot release requirements
  • Review early-stage analytical testing in support of GLP and GMP clinical protocols and production activities
  • Management of quality system records including change requests, deviations and CAPA for the early-stage manufacturing and analytical science departments.
  • BA/BS with 7+ years of experience with biotechnology, pharmaceuticals or human healthcare industries
  • 7+ years experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions.
  • Demonstrate in-depth understanding and application of phase appropriate GMP principles, concepts, practices and standards in the US and internationally.
Pay Scale:
  • $51-60 per hour (Dependent on Experience)
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal opportunity employer.
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