Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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. The role also includes leveraging Veeva Vault and other vendor management tools to ensure efficient oversight and documentation of vendor performance.

Key Responsibilities

• Operationalize approved audit plans and strategies for R&D GCP audits (External & Internal audits), considering relevant regulations and industry standards.
• Perform on-site or remote audits (routine, for-cause/directed); Evaluate compliance with GCP regulations and internal quality standards.
• Prepare comprehensive audit reports outlining findings, observations, and recommendations for corrective actions.
• Ensure vendors comply with GCP, ICH guidelines, FDA regulations, and company policies.
• Develop and implement a robust audit strategy for vendors involved in clinical trials.
• Lead GCP audits of vendors, identifying gaps and implementing corrective and preventive actions (CAPAs).
• Utilize Veeva Vault QualityDocs for managing audit findings, CAPAs, and compliance documentation.
• Lead the selection and qualification of vendors, including Contract Research Organizations (CROs), central laboratories, and data management providers.
• Oversee contract negotiations, including Service Level Agreements (SLAs) and Key Performance Indicators (KPIs).
• Develop and manage performance metrics and vendor scorecards.
• Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and Procurement teams.
• Identify and mitigate risks associated with vendor partnerships and trial execution.

Qualifications & Requirements

• 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.

Supervisory Responsibilities

• 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.
• Management of contract auditors.

Travel

• Flexible to travel, including international.
• May require up to 35% travel, sometimes with short notice time.
• Anticipating min 2 audits/month.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.