Director of Quality Assurance - 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

• Strong knowledge of GLP, GCLP, FDA, and international regulatory standards with experience in CRO.
• Proven experience in managing regulatory inspections and audits.
• Excellent organizational and communication skills, with attention to detail.
• Ability to develop and mentor QA team members and promote a culture of quality.