What are the responsibilities and job description for the Senior Director of Quality Assurance position at TGI Life Sciences?
About the Company
Join a leading global Contract Research Organization (CRO) specializing in solid-state research and drug development . This innovative company is recognized for its cutting-edge solutions in preclinical development and formulation optimization , catering to top-tier pharmaceutical and biotech clients around the world. The organization is dedicated to delivering exceptional quality results to expedite market access for its partners.
About the Position
We are looking for a dynamic and detail-oriented Senior Director of Quality Assurance (QA) . In this pivotal role, you will be essential in ensuring that all operations comply with regulatory standards, maintaining readiness for inspections, and instilling a culture of excellence and quality throughout the organization.
This position is based in Bay Area, CA.
Responsibilities
- Oversee and manage client and regulatory inspections, ensuring thorough preparation and timely submission of responses.
- Ensure comprehensive compliance throughout the organization with GLP, GCLP, FDA, and international regulatory standards.
- Maintain an inspection-ready status by overseeing the preparation and management of documentation.
- Develop, implement, and monitor QA standard operating procedures (SOPs), audit logs, and maintain the company's Master Schedule.
- Conduct internal and external audits to guarantee regulatory compliance.
- Provide training on GLP and GCLP standards to staff and encourage a culture of quality excellence.
- Proactively monitor regulatory updates and adjust business processes to stay compliant.
- Recruit, mentor, and lead a high-performing QA team.
- Create and manage a Risk Register, proactively addressing compliance challenges.
- Prepare compliance reports for leadership and represent QA at company meetings.
Qualifications
