Director of Quality Assurance

About the companyI 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 positionI 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.ResponsibilitiesManage 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.QualificationsStrong 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.

Created: 2025-01-28