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.
Summary:
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.
Duties:
- 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).
Requirements:
- 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.