Associate Director, Good Clinical Practice – Audit and Vendor Management
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: United Kingdom
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Job Level
Tech Stack
About the role
- Lead the strategy, execution, and oversight of vendor management and GCP audit activities to ensure compliance with GCP regulations.
- Ensure clinical trials and all vendors adhere to internal quality standards, regulatory requirements, and contractual agreements.
- Audit planning, preparation, conduct, and reporting for R&D GCP audits.
- 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.
- Develop and manage performance metrics and vendor scorecards.
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).
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GCP auditingvendor managementclinical operationsquality assuranceaudit planningperformance metricsvendor scorecardsGCP complianceaudit readinessICH guidelines
Soft Skills
leadershipcommunicationanalytical skillsproblem-solvingproject managementstakeholder management