Clinical Development Quality Assurance, Associate Director

Position Purpose

• Provide overall quality and compliance during clinical development processes (GCP, GLP, GCLP).
• Plan and conduct GCP/GLP/GCLP audits independently or as a lead or team member.
• Support functional activities related to pre‑clinical and clinical development to ensure regulatory compliance and quality standards.
• Serve as a GCP and GLP partner with stakeholders to solve compliance issues, drive quality improvements, and enhance animal, human research practices, patient safety, and data integrity.

Accountabilities / Responsibilities

• Plan and conduct global GCP/GLP/GCLP audits independently, as a lead, team member, or in a supportive role.
• Communicate and document audit findings, compile corrective and preventive action (CAPA) evidence.
• Maintain and contribute to an audit program covering clinical investigator sites, external service providers, and internal processes.
• Support the deve...