Director, Clinical Quality Assurance
Core
Develops strategy and operates plans for Clinical Quality Assurance, ensuring compliance with GCP and leading a team of quality managers to support clinical study teams.
Role type
Director, Clinical Quality Assurance
Builds
Clinical Quality Management Systems (QMS) and compliance frameworks for clinical trials
Domain
Biopharmaceuticals / Clinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
GCP leadership, clinical audit strategy, regulatory inspection management, cross-functional stakeholder management, budget and schedule oversight, corrective action planning, vendor/investigator oversight, GxP knowledge
Preferred skills
Strategic thinking, change management, mentorship, risk-based management
Technologies
None explicitly listed
Responsibilities
Develop executive strategy for Clinical QA; lead GCP QA vision and culture; partner with Clinical Development, Biostatistics, and Regulatory Affairs; prepare for and lead regulatory inspections; develop and enhance clinical QMS; oversee global clinical investigators, CROs, and labs; monitor regulatory status of principal investigators; support IND/CTA applications; develop compliance metrics; perform site and vendor audits; oversee drug safety and pharmacovigilance compliance
Seniority
Director, strategic leadership with hands-on operational oversight
