Associate Director Good Clinical Practice Audit and Vendor Management
Associate Director Good Clinical Practice Audit and Vendor Management
Posted on :
04-03-2025
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1 Vacancy
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Job Description
Job Title: Associate Director Good Clinical Practice (GCP) Audit and Vendor Management
Job Location: Great Britain United Kingdom
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Director
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 crossfunctional 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:
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.
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 crossfunctional 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 onsite or remote audits (routine forcause/directed); Evaluate compliance with GCP regulations internal quality standards and relevant guidelines; Document audit findings deviations and areas of noncompliance; 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 vendorrelated clinical trial activities.
- Serve as the GCP subject matter expert (SME) for vendorrelated compliance matters.
- Utilize Veeva Vault QualityDocs 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 noncompliance incidents.
- Serve as the primary escalation point for vendorrelated 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 vendorrelated 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.
- 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.
- 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 problemsolving skills.
- Ability to manage multiple projects and stakeholders in a fastpaced environment.
- Interacts with all levels of BeiGene.
- Proficiency in relevant vendor management systems.
- PC literacy required: MS Office skills (Outlook Word Excel PowerPoint)
- 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 riskbased quality management (RBQM) principles.
- Advanced experience in Veeva Vault Quality Suite implementation and management.
- 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.
- 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.
- Flexible to travel including international.
- May require up to 35% travel sometimes with short notice time.
- Audit travel mostly overnight for onsite audits is required anticipating min 2 audits/month.
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
- SelfAwareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- ResultsOriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
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Employment Type
Full Time
Key Skills
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