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- Tasks: Lead GCP audits and ensure compliance with industry standards while managing vendor relationships.
- Company: Join a leading pharmaceutical company dedicated to improving patient outcomes.
- Benefits: Competitive salary, flexible travel, and opportunities for professional growth.
- Why this job: Make a real impact in clinical trials and enhance patient safety through your expertise.
- Qualifications: 8+ years in GCP auditing or vendor management; strong leadership and communication skills.
- Other info: Dynamic role with international travel and mentorship opportunities for junior auditors.
The predicted salary is between 48000 - 84000 £ per year.
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.
- 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.
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.
Global Competencies
- When 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.
- 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
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management in Folkestone employer: BeiGene
Contact Detail:
BeiGene Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management in Folkestone
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with yours. We want you to walk into that interview feeling confident and ready to show them why you’re the perfect fit!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and get comfortable with the process. We believe that the more you practice, the more natural it will feel when it’s time for the real deal.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in leaving a positive impression. We recommend expressing your appreciation for the opportunity and reiterating your enthusiasm for the role.
We think you need these skills to ace Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management in Folkestone
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in GCP auditing and vendor management. We want to see how your skills align with the key responsibilities outlined in the job description.
Showcase Your Experience: When detailing your work history, focus on specific examples of audits you've conducted or vendor relationships you've managed. We love seeing concrete achievements that demonstrate your expertise in the field.
Be Clear and Concise: Keep your application straightforward and to the point. Use clear language and avoid jargon where possible. We appreciate a well-structured application that makes it easy for us to see your qualifications.
Apply Through Our Website: Don’t forget to submit your application through our official website! It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at BeiGene
✨Know Your GCP Inside Out
Make sure you brush up on your knowledge of Good Clinical Practice (GCP) regulations and guidelines. Be prepared to discuss how you've applied these in past roles, especially in audit settings. This will show that you're not just familiar with the theory but can also operationalise it effectively.
✨Showcase Your Vendor Management Skills
Since vendor management is a key part of this role, think of specific examples where you've successfully managed vendor relationships or audits. Highlight any strategies you've implemented to ensure compliance and performance, as this will demonstrate your hands-on experience.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations, such as dealing with non-compliance or conducting an audit under tight timelines. Practising your responses to these scenarios can help you articulate your problem-solving skills and decision-making process during the interview.
✨Familiarise Yourself with Veeva Vault
Since the role involves using Veeva Vault for managing audit findings and vendor performance, make sure you understand its functionalities. If you have experience with it, be ready to discuss how you've used it in previous roles. If not, do some research to show your willingness to learn and adapt.