Associate Director, GCP Inspection Lead EMEA

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August 13

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BeOne Medicines

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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.

10,000+ employees

Founded 2010

📋 Description

• Supervises inspection readiness activities, guiding inspections by health authorities such as the FDA, EMA, and others. • Assign inspection requests to subject matter experts and provide real-time guidance to ensure seamless inspection processes. • Work alongside cross-functional clinical study teams to develop and implement a cohesive inspection readiness strategy. • Manage and optimize the Inspection Readiness Checklist, develop engaging storyboards, and lead mock inspections to identify and mitigate risks effectively. • Create and refine SOPs and tools that enhance our inspection readiness and management capabilities. • Implement and uphold key QA systems including investigations, Significant Quality Events (SQEs), and CAPAs to ensure compliance and excellence. • Demonstrate exceptional problem-solving abilities by conducting thorough evaluations in high-pressure situations. • Manage all aspects of inspection commitments and engage in post-inspection processes to ensure timely resolutions. • Organize lessons learned sessions after inspections, identifying trends and best practices that can elevate our quality processes. • Mentor colleagues, fostering a culture of continuous improvement.

🎯 Requirements

• Bachelor’s degree required; advanced degrees preferred. • Prior experience leading independently inspections from Health Authorities (MHRA, EMA, etc.) • In-depth knowledge of FDA, EU, and ICH GCP guidelines. • A minimum of 7 years of experience in GCP-related Quality Assurance within pharmaceutical, biotechnology, or healthcare industries. • High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries. • Fluency in English; additional language skills (e.g., Spanish, German, French) are a plus. • Superior verbal and written communication skills. • Ability to thrive in a dynamic, collaborative environment.