Associate Director, 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.

Operationalize approved audit plans and strategies for R&D GCP audits (External & Internal audits), considering relevant regulations and industry standards;
Coordinate audit schedules and necessary resources with relevant stakeholders:
Review documentation, procedures, and quality management systems prior to conducting audits.

Perform on-site or remote audits (routine, for-cause/directed);
Evaluate compliance with GCP regulations, internal quality standards, and relevant guidelines;
Document audit findings, deviations, and areas of non-compliance;
Interview personnel, review records, and gather evidence during audits.

Prepare comprehensive audit reports outlining findings, observations, and recommendations for corrective actions;
Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures and ensure effective CAPA are provided by

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).

Ensure audit and inspection readiness across all vendor-related clinical trial activities.

Serve as the GCP subject matter expert (SME) for vendor-related compliance matters.

Utilize Veeva Vault Quality Docs for managing audit findings, CAPAs, and compliance documentation.

Develop and implement a comprehensive GCP vendor management strategy.

Lead the selection and qualification of vendors, including Contract Research Organizations (CROs), central laboratories, and data management providers.

Establish and maintain strong vendor relationships to ensure successful collaboration.

Manage vendor onboarding and performance tracking using Veeva Vault Supplier Management

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
.

Develop and manage performance metrics and vendor scorecards.

Conduct regular vendor audits and quality assessments.

Address and resolve performance issues, deviations, and non-compliance incidents.

Serve as the primary escalation point for vendor-related concerns.

Utilize Veeva Vault Quality Suite for tracking vendor performance and reporting.

Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and Procurement teams.

Provide leadership and guidance to internal stakeholders on vendor-related GCP compliance and audit…