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

Responsibilities

• Audit Planning, Preparation, Conduct and Reporting:
• 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
• GCP Compliance, Audits & Oversight:
• 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 QualityDocs for managing audit findings, CAPAs, and compliance documentation.
• Vendor Strategy & Oversight:
• 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
• Contracting & Compliance:
• 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 .
• Vendor Performance Management:
• 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.
• Collaboration & Stakeholder Management:
• 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 matters.
• Lead vendor governance meetings and performance reviews.
• Train internal teams on the use of Veeva Vault for vendor oversight and document management.
• Risk Management & Continuous Improvement:
• Identify and mitigate risks associated with vendor partnerships and trial execution.
• Drive process improvements to enhance vendor oversight, auditing, quality assurance, and GCP compliance.
• Stay updated on regulatory changes and industry best practices.
• Implement and optimize Veeva Vault solutions to improve vendor management efficiency.
• 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, GC

Benefits

Additional Information

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 trial s 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.

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