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Technical Manager, Clinical QA

Novato, CA 94949

Posted: 04/01/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 602392 Is job remote?: No Country: United States

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).
Requirements:
  • 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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