Director, Clinical QA
Core
Develop strategy and operate plans for Clinical Quality Assurance (QA) to ensure compliance with GCP and regulatory standards across clinical studies.
Role type
Director, Clinical QA
Builds
Quality systems, audit programs, and compliance frameworks for clinical trials.
Domain
Biopharmaceuticals / Clinical Research / Regulatory Compliance
Deliverable
client delivery
Required skills
GCP leadership, regulatory inspection management, audit strategy, cross-functional stakeholder management, budget and schedule oversight, corrective action planning, GxP knowledge, team leadership, risk-based quality management
Preferred skills
Strategic thinking, change management, mentorship, complex problem solving, relationship building
Technologies
None explicitly listed
Responsibilities
Develop executive strategy for Clinical QA; lead regulatory inspections and audit preparations; oversee compliance activities for drug safety and pharmacovigilance; manage global clinical investigators and CROs; develop metrics for compliance activities; lead the Clinical QA team.
Seniority
Director, strategic leadership with hands-on operational oversight
