Novato, CA

Technical Manager, Clinical QA

Clinical Technical Manager/QA

Location: Novato, CA (Hybrid 3 Days on Site)
Assignment: 12 months (Great potential to extend or convert)
Pay Rate: $61/Hr.
Our pharmaceutical client, a global leader in therapeutics for rare and life-threatening genetic diseases, is seeking a Clinical Technical manager that will be represent Clinical Quality Department in overseeing compliance and oversight for internally manufactured early-stage products.

  • Serve Create revise and approve company's Phase Appropriate Quality Systems documentation.
  • Draft and approval of Quality Technical Agreements with CDMOs as required for internal support.
  • Provide support to audits and inspections of CDMOs and internal manufacturing and testing organizations
  • 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.
  • QA Issuance, Review and Approval of manufacturing production batch records in support of 300 BMK manufacturing operations.
  • Perform walkthroughs and other support activities of Analytical Science and Process Development to ensure compliance with applicable GMPs/GLPs.
  • Perform QA Walkthroughs for 300 BMK manufacturing product changeovers.
  • Review and approval of SOP revisions initiated by manufacturing, Facilities and Engineering and Analytical support for 300 BMK Operations.
  • Management of quality system records including change requests, deviations and CAPA for the early-stage manufacturing and analytical science departments.
  • Ensure manufacturing and adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus).


  • Bachelor's degree from an accredited University/College and 7+ years of experience with biotechnology, pharmaceuticals, or human healthcare industries.
  • Background experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions is a PLUS.

  • Max. file size: 300 MB.