Associate Director, Good Clinical Practice (GCP) Audits and Inspections

About the role

The Associate Director, Good Clinical Practice (GCP) Audits and Inspections leads and executes GCP audits, supports regulatory inspection readiness, and provides quality oversight across clinical development programs. This senior quality role ensures compliance with regulatory requirements, protects trial participants, and maintains data integrity.

Key responsibilities

• Lead risk‑based GCP audits (site, vendor, process, internal) and manage audit planning, execution, reporting, and follow‑up.
• Drive inspection readiness activities, support Health Authority inspections, and coordinate post‑inspection CAPA implementation.
• Provide GCP quality leadership for assigned compounds, identifying and mitigating compliance risks.
• Oversee vendor GCP quality, conduct vendor audits, and manage ongoing risk‑based oversight.
• Mentor auditors, contribute to continuous improvement of audit and inspection processes, and maintain awareness of evolving GCP regulations.

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy, Business or related field (Master’s preferred).
• Minimum 8 years of experience in GCP quality assurance, auditing, or regulatory inspection support.
• Proven experience leading GCP audits and inspection readiness activities.
• Strong knowledge of ICH GCP, global clinical trial regulations, and risk‑based quality management.
• Excellent leadership, communication, analytical and problem‑solving skills.

Required skills

• Veeva Vault Quality Suite
• Electronic Trial Master File (eTMF) systems
• Clinical Trial Management Systems (CTMS)
• MS Office (Outlook, Word, Excel, PowerPoint)
• Risk‑based quality management (RBQM) principles