Position Summary
Reporting directly to the CSO, the Director of Quality Assurance (QA) is responsible for developing and overseeing quality systems to ensure compliance with Good Laboratory Practice (GLP) for nonclinical studies and Good Clinical Laboratory Practice (GCLP) for clinical studies. This role ensures that facilities, equipment, personnel, methods, practices, records, and controls adhere to regulatory standards.
Key Responsibilities
- Host client and regulatory inspections, including preparing responses to findings.
- Support regulatory professionals across BABM sites.
- Ensure GLP protocol requirements are met by auditing raw data, data summary tables, and phase reports for nonclinical studies and bioanalytical sample analysis.
- Maintain a state of inspection readiness, including site-specific folders.
- Ensure compliance with GLP, GCLP, and GCPs for FDA and international regulations.
- Manage the company Master Schedule.
- Develop and maintain QA Standard Operating Procedures (SOPs), QA Files, and QA Audit Log.
- Process and archive QA inspection reports and other required documentation.
- Monitor and interpret regulatory requirements for application to business processes.
- Author and review SOPs and Statistical Analysis Plans (SAP).
- Provide GLP and GCLP training.
- Recruit, develop, manage, and mentor regulatory professionals, fostering a supportive and growth-oriented culture.
- Plan, conduct, and report inspections of internal facilities to TSM.
- Plan, conduct, and report audits of external vendors to assess regulatory compliance.
- Manage the company Risk Register.
- Identify regulatory compliance issues and provide support to departments.
- Provide TSM with monthly compliance status reports, including issues and corrective actions.
- Represent QA in company meetings.
Qualifications and Educational Requirements
- BA/BS degree in biological/physical sciences required; advanced degrees (MA, PhD) preferred.
- 10+ years of relevant Regulatory Affairs experience in the Bioanalytical CRO space and/or biotechnology/pharmaceutical industry, or a combination of education and experience.
- Ability to provide regulatory leadership and guidance on cross-functional teams and work in a matrixed environment.
- Strategic thinker capable of planning and proposing innovative solutions to regulatory challenges.
