Associate Director, GLP Quality

Key Responsibilities

• Lead quality oversight of non-clinical studies conducted at CROs, contract laboratories, bioanalytical laboratories, toxicology sites, and other external partners supporting development programs
• Develop and maintain a risk-based vendor oversight model, including qualification, onboarding, performance monitoring, audits, issue escalation, and periodic review
• Plan, conduct, and manage GxP audits; drive timely closure of findings and CAPAs with effectiveness verification
• Review study- and vendor-related quality documentation, including protocols, reports, deviations, CAPAs, change controls, quality agreements, and data integrity concerns, as applicable
• Lead investigations, root cause analysis, and CAPA activities associated with non-clinical quality events and vendor performance issues, including trending and recurrence prevention
• Maintain inspection readiness for non-clinical activities through controlled documentation, evidence packages, and support for regulatory inspections, partner audits, and due diligence reviews
• Provide guidance and training to internal teams and external partners to reinforce GLP expectations, documentation discipline, and quality standards
• Contribute to the design, implementation, and continuous improvement of phase-appropriate QMS processes relevant to non-clinical development in a virtual company model

Cross-Functional Partnership

• Provide quality input to governance forums, program teams, and functional leadership on compliance risks, mitigation strategies, and business impact
• Partner with Regulatory Affairs to support quality aspects of IND, CTA, IMPD, NDA/BLA/MAA, or related submissions
• Collaborate across Development, CMC, Technical Operations, and Clinical to ensure quality interfaces are managed effectively across development programs
• Support the build-out of scalable quality infrastructure and mentor junior team members as needed