Associate Director, Clinical Quality Assuranc
About the role
We are seeking a motivated and qualified individual to join our team as an Associate Director, Clinical Quality Assurance. This role provides strategic and operational leadership for the Clinical QA function, ensuring the highest standards of Good Clinical Practice (GCP) compliance across all clinical programs.
Responsibilities
Develop and execute the Clinical QA strategy aligned with organizational and development goals
Develop, implement, maintain and continuously improve phase-appropriate, risk-based clinical quality systems, processes, SOPs and policies to support early and late phase clinical trials and regulatory submissions
Implement proactive, risk-based approaches to identify, assess, and mitigate quality and compliance risks
Provide ongoing GCP quality oversight and support to ensure adherence to global GCP, quality and compliance requirements across all clinical programs
Partner closely with Clinical Operations, Clinical Development, Regulatory Affairs, Data Management, Biometrics, CMC, Clinical Supply Chain and study teams to proactively identify and mitigate compliance risks and ensure operational compliance
Provide Clinical QA oversight for CROs, laboratories, and other clinical vendors. Ensure appropriate qualification, monitoring, and oversight are in place
Review and contribute to key clinical and regulatory documents including INDs, protocols, IBs, NDAs, and other trial and submission-related materials, as applicable
Lead the planning and execution of a comprehensive, risk-based GCP audit program (investigator sites, CROs, vendors, and processes)
Oversee the management of audit findings and drive effective CAPA implementation
Oversee and support investigations of deviations, noncompliance and quality events, ensuring thorough root cause analysis, CAPA implementation and proper documentation
Lead organizational inspection readiness activities for late phase programs and global regulatory authority inspections (e.g., FDA, EMA)
Ensure systems are inspection-ready and aligned with evolving regulatory expectations
Serve as Clinical QA lead for regulatory inspections, including preparation, hosting, and post-inspection response management
Support NDA/BLA/MAA submission activities from a quality perspective
Influence and embed quality principles across the clinical development lifecycle
Develop and deliver annual GCP training programs and quality-related trainings
Communicate regulatory changes, best practices and compliance expectations to internal stakeholders
Collaborate closely with the broader Quality team to execute Quality objectives and ensure alignment across GxP areas
Foster a culture of inspection readiness and continuous improvement across the organization
Qualifications
Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree preferred
10+ years of progressive GCP Quality Assurance experience in the biotechnology or pharmaceutical industry
Direct experience supporting late-stage clinical trials (Phase 2/3) and NDA/MAA submission preparation, with proven inspection readiness experience
Expert knowledge of global GCP regulations and guidance, including but not limited to: 21 CFR Parts 11, 50, 54, 56, 312 EU Clinical Trial Regulation (EU-CTR) ICH E6(R2/R3), ICH E8 General Data Protection Regulation (GDPR) Good Clinical Laboratory Practice (GCLP)
Extensive experience leading GCP audits (internal, investigator sites, CROs, and vendors) and managing regulatory inspections
Demonstrated ability to operate both strategically and hands-on in a small, fast-paced biotech environment
Excellent communication, collaboration, and influencing skills across cross-functional teams