Associate Director, GCP Quality Oversight

Responsibilities

• Leads GCP quality oversight for global clinical program(s) to ensure sustained compliance, inspection readiness across internal teams.
• Implements standards for risk-based oversight, issue management rigor, translating quality signals into cross-functional actions that protect participants and data integrity.
• Oversees quality performance across a portfolio of programs and studies, ensuring measurable recurrence reduction.
• Provides executive-ready reporting on quality risks, trends, and readiness.
• May lead/mentor GCP quality staff.

Requirements

• Minimum 10 years in clinical quality assurance
• Minimum 3 years experience in a clinical operations role at a CRO or Sponsor
• Demonstrated experience conducting and/or overseeing vendor, investigator site, Document/TMF, and process audits.
• BS+ in Life Sciences or related discipline (Preferred)
• Experience leading global health authority inspection readiness and responses (e.g., FDA) across sponsor‑led and outsourced models (Preferred)
• Experience implementing/optimizing eQMS workflows and quality metrics frameworks for GCP oversight at scale; Veeva Quality a plus (Preferred)

Core Competencies

Demonstrates extensive expertise in GCP quality oversight, ensuring compliance and inspection readiness while leading cross‑functional actions to protect participant safety and data integrity. Proficient in implementing quality metrics frameworks and optimizing eQMS workflows for global clinical programs.