Associate Director, Clinical Practice; GCP Audit and Vendor Management

Position: Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management
This position within R&D Quality, Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management is a senior role responsible for leading the strategy, execution, and oversight of vendor management and GCP audit activities to ensure compliance with GCP regulations.

This role ensures that clinical trials and all vendors adhere to internal quality standards, regulatory requirements, and contractual agreements, thereby supporting the integrity and success of clinical research.

The position involves leadership, cross-functional collaboration, regulatory engagement, and continuous improvement initiatives to optimize vendor management, auditing, and clinical trial compliance. The position will play a critical role in safeguarding the integrity, safety, and quality of clinical research processes and data
* Oversee contract negotiations, including Service Level Agreements (SLAs) and Key Performance Indicators (KPIs).
* Maintain thorough documentation related to vendor qualifications, contracts, and compliance reports.
* Ensure all vendor contracts, audits, and compliance reports are accurately documented in
** Veeva Vault**.
* 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 within the pharmaceutical, biotechnology, or clinical research industry.
* Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
* Proven experience in GCP compliance, audit readiness, and vendor performance management.
* Experience with
** Veeva Vault
** for quality management, audit tracking, and vendor oversight.
* Excellent leadership, communication, analytical, and problem-solving skills.
* Ability to manage multiple projects and stakeholders in a fast-paced environment.
* Interacts with all levels of Bei Gene.
* Proficiency in relevant vendor management systems.
* PC literacy required: MS Office skills (Outlook, Word, Excel, PowerPoint)
* 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.
* This position may include managing staff (junior auditor): coaching and mentoring of junior auditors, with training/orientation/qualification and development plan for new Quality staff, required. Therefore, it may require to have certain leadership experience and mentoring skills. It also includes management of contract auditors.
* Mentor and provide support to R&D auditors personnel, as needed.
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