PBeOne 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. /ppThis position within RD 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. /ppThis 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. /ppThe 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 /ppThe role also includes leveraging bVeeva Vault /b and other vendor management tools to ensure efficient oversight and documentation of vendor performance. /ppbKey Responsibilities: /b /ppbAudit Planning, Preparation, Conduct and Reporting: /b /plipOperationalize approved audit plans and strategies for RD 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. /p /lilipPerform 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. /p /lilipPrepare 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 /p /lipbGCP Compliance, Audits Oversight: /b /plipEnsure vendors comply with GCP, ICH guidelines, FDA regulations, and company policies. /p /lilipDevelop and implement a robust audit strategy for vendors involved in clinical trials. /p /lilipLead GCP audits of vendors, identifying gaps and implementing corrective and preventive actions (CAPAs). /p /lilipEnsure audit and inspection readiness across all vendor-related clinical trial activities. /p /lilipServe as the GCP subject matter expert (SME) for vendor-related compliance matters. /p /lilipUtilize bVeeva Vault QualityDocs /b for managing audit findings, CAPAs, and compliance documentation. /p /lipbVendor Strategy Oversight: /b /plipDevelop and implement a comprehensive GCP vendor management strategy. /p /lilipLead the selection and qualification of vendors, including Contract Research Organizations (CROs), central laboratories, and data management providers. /p /lilipEstablish and maintain strong vendor relationships to ensure successful collaboration. /p /lilipManage vendor onboarding and performance tracking using bVeeva Vault Supplier Management /b /p /lipbContracting Compliance: /b /plipOversee contract negotiations, including Service Level Agreements (SLAs) and Key Performance Indicators (KPIs). /p /lilipMaintain thorough documentation related to vendor qualifications, contracts, and compliance reports. /p /lilipEnsure all vendor contracts, audits, and compliance reports are accurately documented in bVeeva Vault /b. /p /lipbVendor Performance Management: /b /plipDevelop and manage performance metrics and vendor scorecards. /p /lilipConduct regular vendor audits and quality assessments. /p /lilipAddress and resolve performance issues, deviations, and non-compliance incidents. /p /lilipServe as the primary escalation point for vendor-related concerns. /p /lilipUtilize bVeeva Vault Quality Suite /b for tracking vendor performance and reporting. /p /lipbCollaboration Stakeholder Management: /b /plipPartner with Clinical Operations, Quality Assurance, Regulatory Affairs, and Procurement teams. /p /lilipProvide leadership and guidance to internal stakeholders on vendor-related GCP compliance and audit matters. /p /lilipLead vendor governance meetings and performance reviews. /p /lilipTrain internal teams on the use of bVeeva Vault /b for vendor oversight and document management. /p /lipbRisk Management Continuous Improvement: /b /plipIdentify and mitigate risks associated with vendor partnerships and trial execution. /p /lilipDrive process improvements to enhance vendor oversight, auditing, quality assurance, and GCP compliance. /p /lilipStay updated on regulatory changes and industry best practices. /p /lilipImplement and optimize bVeeva Vault /b solutions to improve vendor management efficiency. /p /lipbQualifications Requirements: /b /plipBachelor’s degree in Life Sciences, Pharmacy, Business, or related field (Master’s preferred). /p /lilip8+ years of experience in vendor management, clinical operations, GCP auditing, or quality assurance within the pharmaceutical, biotechnology, or clinical research industry. /p /lilipStrong knowledge of GCP, ICH guidelines, and global regulatory requirements. /p /lilipProven experience in GCP compliance, audit readiness, and vendor performance management. /p /lilipExperience with bVeeva Vault /b for quality management, audit tracking, and vendor oversight. /p /lilipExcellent leadership, communication, analytical, and problem-solving skills. /p /lilipAbility to manage multiple projects and stakeholders in a fast-paced environment. /p /lilipInteracts with all levels of BeiGene. /p /lilipProficiency in relevant vendor management systems. /p /lilipPC literacy required: MS Office skills (Outlook, Word, Excel, PowerPoint) /p /lipbPreferred Qualifications: /b /plipCertification in GCP auditing or clinical research is a plus. /p /lilipExperience working with electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS). /p /lilipFamiliarity with risk-based quality management (RBQM) principles. /p /lilipAdvanced experience in bVeeva Vault Quality Suite /b implementation and management. /p /lipbSupervisory Responsibilities: /b /plipThis 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. /p /lilipMentor and provide support to RD auditors personnel, as needed. /p /lipbTravel: /b /plipFlexible to travel, including international. /p /lilipMay require up to 35% travel, sometimes with short notice time. /p /lilipAudit travel mostly overnight for on-site audits is required - anticipating min 2 audits/month. /p /lipGlobal Competencies /ppWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. /pliFosters Teamwork /liliProvides and Solicits Honest and Actionable Feedback /liliSelf-Awareness /liliActs Inclusively /liliDemonstrates Initiative /liliEntrepreneurial Mindset /liliContinuous Learning /liliEmbraces Change /liliResults-Oriented /liliAnalytical Thinking/Data Analysis /liliFinancial Excellence /liliCommunicates with Clarity /li