Director, Clinical Quality Assurance (GCP)
Core
Lead GCP auditing efforts including internal, site, and vendor audits to ensure clinical trial compliance and quality standards.
Role type
Director, Clinical Quality Assurance (GCP)
Builds
Compliance with GCP guidelines and regulatory requirements for clinical trials
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
GCP guidelines expertise, ICH E6(R2) knowledge, clinical trial audit leadership, risk-based audit planning, QMS assessment, regulatory inspection readiness, cross-functional collaboration
Preferred skills
RAC or CQA certification, pharmacovigilance auditing experience, Veeva systems expertise
Technologies
Veeva systems
Responsibilities
Lead and manage the Clinical Quality Assurance audit program; Provide leadership and mentorship to CQA staff and contract auditors; Develop and execute risk-based audit plans; Review and approve essential study documents; Represent the company in regulatory inspections; Develop and implement GCP training programs
Seniority
Director, strategic leadership & team management
