Quality Assurance Manager/Senior Manager

Position Summary

The Quality Assurance Manager/Senior Manager manages the development and oversight of our Quality Management System and supports the GLP and GMP activities (both internal and external) required for our portfolio of vaccine programs.

 

Primary responsibilities

  • Formulate, establish and maintain policies and procedures and accompanying Quality Systems related to cGMP manufacturing and ensuring these systems comply with US FDA and global regulatory requirements
  • Establish and maintain an overall Quality System to support clinical cGMP activities
  • Support cGMP document control system
  • Coordinate and provide oversight of lot disposition for bulk drug substance, drug product and packaged product for clinical use (including timely management of batch record review, resolution of deviations, review and approval of in-process and lot release testing records, issuance of Certificates of Conformance and Certificates of Analysis)
  • Establish and maintain robust and compliant deviation management, CAPA, and change control systems/processes
  • Interact with Genocea personnel and contract manufacturing organizations and contract test laboratories to coordinate and monitor quality aspects of production and testing activities
  • Review and approve clinical assay test methods and make recommendations for process improvements and clarity
  • Perform QA review of clinical immunology and efficacy assay data in support of clinical trials
  • Maintain Quality Agreements with external contractors and ensure requirements are met
  • Maintain an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Quality System activities

 

Required Skills

  • Broad knowledge of phase appropriate Quality System implementation and maintenance including batch record review, batch/lot disposition, deviation management, CAPA programs, and change control programs
  • Knowledge and experience with risk-based approach to Quality System implementation
  • Strong analysis and problem solving skills
  • Ability to work in a dynamic, fast paced environment with shifting priorities
  • Ability to work collaboratively to resolve deviations, develop effective CAPAs, and identify requirements to implement changes in a controlled GMP environment

 

Education and Experience Required

  • Bachelor’s Degree in life science or a related scientific discipline; graduate degree is a plus
  • 10+ years’ experience in QA management of biologic or vaccine products
  • Previous experience working with clinical stage products for human use
  • Working knowledge of cGMP principles with respect to FDA and EMA regulations
  • Familiarity with aseptic processing regulations and guidelines
  • Management of key Quality Systems including batch record review and product disposition, change management, document control, deviations management, training, and CAPA
  • Experience with quality oversight and auditing of external vendors in the GMP environment

*Title will be commensurate with candidate’s background and experience.

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