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Senior Director - Quality Assurance GMP - San Francisco

Company: Meet
Location: San Francisco
Posted on: January 17, 2020

Job Description:

-Director - Quality Assurance- GMP - San Francisco Bay Area - - Our client, an oncology focused , has partnered with us to locate a Director of Clinical Compliance. - The Director of Quality Assurance ensures compliance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products. This role will require knowledge of current trends with regards to ICH and US regulatory inspections and expectations. Also desirable: EU regulatory knowledge. - - - CANDIDATE QUALIFICATIONS: - Management experience in a sterile manufacturing environment (Aseptic experience) Quality/ Pharma experience B.A. or B.S. in scientific field and/or equivalent. Minimum of ten (10) years' progressive experience in a regulated cGMP industry is required, with five (5) years' management experience. Experience in a GMP parenteral manufacturing environment Strong knowledge of GMP regulations, guidance, and general compliance expectations. Regulatory inspection hosting experience mandatory, with experience for with global jurisdictions preferred. - JOB RESPONSIBILITIES - Conduct GMP investigations, including: Root cause analysis. Risk assessment. Impact evaluation. Technical report writing. Troubleshoot systemic issues and develop solutions. Review and approve controlled documents requiring QA approval signature, including: Client Audit Observations Internal Audit Reports/Responses Execute cGMP Batch Records Master Batch Production Records Process Simulation/Process Validation Protocols Standard Operating Procedures Material Specifications Stability Protocols Qualification Protocols. -

Keywords: Meet, San Francisco , Senior Director - Quality Assurance GMP - San Francisco, Professions , San Francisco, California

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