Senior Manager, Quality Assurance

Location
92121, San Diego
Posted
Sep 28, 2021
Hotbed
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time

Key Responsibilities:

 

  • Manage the QA controlled document management system and perform associated activities as required.
  • Participate in the evaluation, selection, validation, migration, and implementation of an electronic data management system.
  • Manage the QA training program and perform associated activities as required.
  • Implement and manage the QA non-conformance system and perform associated activities as required.
  • Process documents and maintain records and databases in accordance with procedures.
  • Ensure that Artiva GMP, GCP, GLP (GXP) activities continue to meet corporate, quality, and regulatory standards for early phase US clinical trials.
  • Implement and manage new procedures as required for compliance with FDA regulations, guidelines, and expectations.
  • Alert organization to changing cell product compliance requirements and industry best practices.
  • Identify GXP compliance risks develop appropriate courses of actions.
  • Participate in hiring quality assurance staff.
  • Develop and manage department performance metrics.
  • Conduct GXP training per FDA and US guidelines.

 

Qualifications:

 

  • BS or BA in a scientific field.
  • 10+ years of US and EU regulatory compliance experience in biologics or pharmaceutical development.
  • 3+ years of people management experience.
  • Experience with inspections by regulatory authorities
  • Demonstrated ability to apply comprehensive, in-depth, understanding of pharmaceutical industry regulatory compliance requirements with an emphasis on GMP/GLP/GCP related issues, and related US and international laws.
  • Thorough knowledge of current Good Manufacturing Practices and aseptic processing guidelines as they relate to the production of cell therapy products for human clinical trials.
  • Sound basis of scientific (Training/Communications) knowledge.
  • Expert knowledge of quality regulations, current industry practices, and strong experience with interpretation and application.
  • Computer skills required to operate Microsoft Word, Project and Excel programs.

Artiva is an Equal Opportunity Employer