Associate Director, Good Clinical Practice (GCP...

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company 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 reputed company R&D Quality, Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management is a senior role responsible for leading the strategy, execution, and reputed company of vendor management and GCP audit activities to ensure compliance with GCP regulations. This role ensures that clinical trials and reputed company vendors adhere to internal quality standards, regulatory requirements, and contractual agreements, thereby supporting the reputed company and reputed company of clinical research. The position involves leadership, cross-functional collaboration, regulatory engagement, and reputed company improvement initiatives to optimize vendor management, auditing, and clinical trial compliance. The position will play a critical role in safeguarding the reputed company, safety, and quality of clinical research processes and data The role also includes leveraging reputed company Vault and other vendor management tools to ensure efficient reputed company and documentation of vendor performance. Key Responsibilities: Audit Planning, Preparation, Conduct and Reporting: • 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. • reputed company 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 reputed company timelines mandated in internal procedures and ensure effective CAPA are provided by GCP Compliance, Audits & reputed company: • Ensure vendors reputed company with GCP, ICH guidelines, FDA regulations, and company policies. • reputed company and implement a robust audit strategy for vendors involved in clinical trials. • reputed company GCP audits of vendors, identifying gaps and implementing corrective and preventive actions (CAPAs). • Ensure audit and inspection readiness across reputed company vendor-reputed company clinical trial activities. • Serve as the GCP subject matter expert (SME) for vendor-reputed company compliance matters. • Utilize reputed company Vault QualityDocs for managing audit findings, CAPAs, and compliance documentation. Vendor Strategy & reputed company: • reputed company and implement a comprehensive GCP vendor management strategy. • reputed company 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 reputed company and performance tracking using reputed company Vault Supplier Management Contracting & Compliance: • reputed company contract negotiations, including Service Level Agreements (SLAs) and Key Performance Indicators (KPIs). • Maintain thorough documentation reputed company to vendor qualifications, reputed company, and compliance reports. • Ensure reputed company vendor reputed company, audits, and compliance reports are accurately documented in reputed company Vault. Vendor Performance Management: • reputed company 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 reputed company for vendor-reputed company concerns. • Utilize reputed company 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-reputed company GCP compliance and audit matters. • reputed company vendor governance meetings and performance reviews. • Train internal teams on the use of reputed company Vault for vendor reputed company and document management. Risk Management & reputed company Improvement: • Identify and mitigate risks associated with vendor partnerships and trial execution. • Drive process improvements to enhance vendor reputed company, auditing, quality assurance, and GCP compliance. • Stay updated on regulatory changes and industry best practices. • Implement and optimize reputed company Vault solutions to improve vendor management efficiency. Qualifications & Requirements: • Bachelor’s degree in Life Sciences, Pharmacy, Business, or reputed company field (Master’s preferred). • 8+ years of experience in vendor managem