Manager, Development QA

Department
Development QA

Location
San Diego

Summary Description
The Manager, Development QA will be based at PaxVax’s San Diego, California location and responsible for the quality oversight and supporting the Operations group for the manufacture and testing of non-clinical and clinical materials. The ideal candidate will have 7-10 years’ experience in the pharmaceutical / biotech industry, with 6+ years of QA experience supporting GMP manufacturing. This position reports directly to the AD, Development QA.

Responsibilities:

  • Review and approval of master batch records
  • Review and approval of executed batch records and associated analytical data related to the manufacture of drug substances and drug products
  • Support the disposition of raw materials, intermediates, drug substances and drug products
  • Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments
  • Quality monitoring of in-house and CMO manufacturing operations
  • Supports equipment, utility and facility qualification activities
  • Performs Quality review of test method validation, cleaning verification/validation, stability studies and process validation documents
  • Independently performs Quality review and release of raw materials
  • Write, review and approve GMP documentation (SOPs, protocols, reports)
  • Supports review of CMC sections of regulatory submissions
  • Aid in implementing process improvements with respect to Quality Assurance
  • Supports external agency and internal audits as required

Requirements:

  • BA/BS/MS in in biological sciences, Chemistry or relevant discipline
  • A minimum of 7-10 years’ experience in the pharmaceutical / biotech industry
  • 6 + years of increasing responsibility and relevant QA experience in a pharmaceutical/biotechnology environment supporting GMP manufacturing of biologics for clinical and commercial use
  • Working knowledge of cGMP principles with respect to FDA and EMA and ICH regulations
  • Experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, batch records)
  • Experience in deviations, investigations, determining root cause, and developing corrective action plans
  • Knowledge of drug development process
  • Experience in process justification, process validation, risk assessment
  • Ability and experience to identify technical manufacturing problems and suggest resolution of issues
  • Ability to independently analyze/resolve moderate to complex issues.
  • Demonstrated initiative and accountability in a fast paced environment.
  • Demonstrated proficiency in application of QA principles, concepts, industry practices and standards
  • Problem solving skills, effective written and verbal communication skills
  • Excellent documentation skills and attention to detail
  • Highly organized and ability to manage multiple priorities
  • Ability to work independently and with various work groups
  • Working knowledge of MS Office suite (Word, Power Point, Excel)
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