Technical Manager, Clinical QA
300 Bel Marin Keys Blvd. Novato, CA 94949 US
Job Description
- Create revise and approve the company's Phase Appropriate Quality Systems documentation
- Represent Clinical Quality Department in cross functions forums.
- Draft and approval of Quality Technical Agreements with CDMOs as required for internal support
- Provide quality oversight for internally manufactured early-stage products and starting materials
- Provide support to audits and inspections of CDMOs and internal manufacturing and testing organizations
- Provide quality oversight of one or more portions of operations including, but not limited 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.
- 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.
- Review of GMP/GLP documentation from manufacturing and/or Analytical Operations, which can include logbooks, and test records.
- 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).
- BA/BS from an accredited University/College
- 7+ years of experience with biotechnology, pharmaceuticals or human healthcare industries.
- 7+ years experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions.
- Excellent interpersonal and communications skills required. Strong organizational and technical writing skills required.
- Computer literacy required, including Microsoft PowerPoint, Word, Excel.
- Demonstrates strong technical and analytical skills; provides assistance to solving training/employee issues.
- Results oriented; effectively manages a multitude of projects efficiently.
- Demonstrates excellent negotiation skills; develops effective and supportive relationships with the departments supported.
- Experience managing internal and external project stakeholders.
- Excellent written and verbal skills; ability to communicate effectively with all levels of the organization.
- Builds relationships with other functions, shares best practices, and solves shared problems.
- Demonstrates in-depth understanding and application of phase appropriate GMP principles, concepts, practices and standards in the US and internationally.
- Demonstrates substantial knowledge of industry best practices and trends.
- Positive, solution focused outlook on daily challenges.
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