Associate Director, Good Clinical Practice

Vor 5 Tagen

Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

BeiGene 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.

General Description:

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:

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. 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, 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. Interacts with all levels of BeiGene. Proficiency in relevant vendor management systems. PC literacy required: MS Office skills (Outlook, Word, Excel, PowerPoint)

Preferred Qualifications:

Certification in GCP auditing or clinical research is a plus. Experience working with electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS). Familiarity with risk-based quality management (RBQM) principles. Advanced experience in Veeva Vault Quality Suite implementation and management.

Education Required:

BA/BS degree required; advanced degree preferred. 8+ years of experience in vendor management, GCP auditing, or quality assurance within the pharmaceutical, biotechnology, or clinical research. GCP Quality Assurance auditor's registration/certification preferred.

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, required. Therefore, it may require to have certain leadership experience and mentoring skills. It also includes management of contract auditors. Mentor and provide support to R&D auditors personnel, as needed.

Travel:  

Flexible to travel, including international. May require up to 35% travel, sometimes with short notice time. Audit travel mostly overnight for on-site audits is required - anticipating min 2 audits/month.

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity

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