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Technical Manager, Clinical QA

Novato, CA 94949

Posted: 05/30/2024 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.

 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Novato, CA

Discover Exciting Job Opportunities in the Vibrant Novato, California Area! Novato, nestled in Marin County and conveniently located near San Francisco, offers job seekers a perfect blend of suburban charm and urban excitement. With its picturesque surroundings, proximity to the wine country, and access to stunning parks like Stafford Lake Park and the Marin Museum of Contemporary Art, Novato provides a dynamic backdrop for career growth. Enjoy the renowned cuisine at spots like Boca Tavern or trek the beautiful trails at Mount Burdell. Don't miss the Novato Theater Company productions or catch a game at the Novato Community Athletic Fields. Start your career journey in Novato today and experience the magic this bustling town has to offer.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.