Senior Manager, Quality Assurance
- 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.
- 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