Associate Director, Clinical Practice; GCP Audit and Vendor Management

Employer Industry: Pharmaceutical and Biotechnology

• Opportunity for career advancement and growth within the organization
• Flexible travel schedule, including potential international travel
• Collaborative work environment emphasizing teamwork and innovation
• Engaging role with the chance to impact the integrity and quality of clinical research
• Support for professional development, including mentoring and training for junior auditors

• Lead the strategy, execution, and oversight of vendor management and GCP audit activities
• Conduct on‑site or remote audits, evaluating compliance with GCP regulations and internal quality standards
• Develop and implement a robust audit strategy for vendors involved in clinical trials
• Partner with cross‑functional teams to ensure vendor‑related GCP compliance and audit readiness
• Utilize Veeva Vault for managing audit findings, CAPAs, and vendor performance documentation

• Bachelor’s degree in Life Sciences, Pharmacy, Business, or related field (Master’s preferred)
• 8+ years of experience in vendor management, clinical operations, GCP auditing, or quality assurance
• Strong knowledge of GCP, ICH guidelines, and global regulatory requirements
• Proven experience in GCP compliance, audit readiness, and vendor performance management
• Proficiency in relevant vendor management systems and PC literacy (MS Office skills)

• Certification in GCP auditing or clinical research is a plus
• Experience working with electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS)
• Familiarity with risk-based quality management (RBQM) principles
• Advanced experience in Veeva Vault Quality Suite implementation and management

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