What are the responsibilities and job description for the Director of Quality Assurance position at TGI Life Sciences?
About the company
I am working with a a global Contract Research Organization (CRO) at the forefront of solid-state research, and drug development, etc . The company is well-known for its innovative solutions in preclinical development and formulation optimization , serving clients from top-tier pharmaceutical and biotech companies worldwide. They are committed to delivering high-quality results to accelerate the path to market for their clients.
About the position
I am seeking a highly motivated and detail-oriented Director of Quality Assurance (QA) . The QA expert will play a critical role in ensuring regulatory compliance across all operations, maintaining inspection readiness, and fostering a culture of quality and excellence within the organization.
The role is based in Bay area, CA.
Responsibilities
- Manage client and regulatory inspections, including preparation and submission of responses.
- Ensure organization-wide compliance with GLP, GCLP, FDA, and international standards.
- Maintain inspection readiness through the preparation and management of documentation.
- Develop, implement, and oversee QA SOPs, audit logs, and the company’s Master Schedule.
- Conduct audits of internal data and external vendors to ensure regulatory compliance.
- Provide GLP and GCLP training to staff and foster a culture of quality excellence.
- Monitor regulatory changes and align business processes accordingly.
- Recruit, mentor, and lead the QA team.
- Create and manage a Risk Register and address compliance issues proactively.
- Deliver compliance reports to leadership and represent QA in company meetings.
Qualifications
