Associate Director, Good Clinical Practice – Audit and Vendor Management

🕒 February 18

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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.