Director, GCP Inspection Management – Americas

🕒 October 9

🇺🇸 United States – Remote

💵 $172k - $232k / year

⏰ Full Time

🔴 Lead

👔 Director

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

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 the 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

• Supervise inspection readiness activities and host and coordinate GCP inspections conducted by regulatory health authorities • Develop, maintain, and ensure execution of a risk-based, proactive GCP Inspection Strategy • Ensure development of inspection risk analyses and risk-mitigation plans and communicate them to cross-functional and Quality Leadership • Supervise and manage collaboration with cross-functional internal and external partners • Ensure development, revision, and maintenance of tools, processes, and procedures for inspection readiness, coordination, and management • Lead Quality professionals and/or consultants conducting GCP inspection readiness, management, and hosting activities • Oversee fulfillment of inspection commitments, communications with Inspectorates/Health Authorities, inspection findings, inspection dossiers, pre-inspection requests, and CAPA closure • Maintain an inspection forecast and inspection outcome tracker • Lead post-inspection lessons-learned sessions and identify trends and best practices for process improvement • Chair quarterly Cross-functional Inspection Oversight Committee meetings • Guide and/or manage creation and revision of procedures • Review trends and report significant investigation, deviation, and system deficiency issues to senior management • Manage the internal training program and coordinate/administer GxP training • Represent R&D Quality in meetings and discussions • Act as R&D Quality Delegate for the Executive Director, R&D Quality, as needed • Support development of inspection data metrics and measures for continuous improvement • Participate in budget forecasting, planning, and tracking • Coach and mentor team members and support onboarding and qualification of new Quality staff • Promote continuous improvement • Support the GCP Inspection Management Team with other inspection types, including GLP and PV inspections • Perform other duties as assigned

🎯 Requirements

• 10+ years of experience in the pharmaceutical/biotechnology industry • 5+ years of experience supporting GCPs and managing/hosting GCP inspections • 10+ years with a Bachelor’s degree, preferably in Science, or MS with 7+ years • Strong global mindset and knowledge of regulations, specific expertise in regulations/requirements/cultural awareness • Strong global knowledge and understanding of international regulations applicable to clinical trials • Proven ability to set strategy for and drive quality process improvement initiatives • Strong leadership, strategic, analytical, mentoring, project management, judgment, and decision-making skills • Ability to manage multiple projects and demanding timelines • Effective management skills in building and supporting highly effective teams • Superb attention to detail and excellent review skills • Ability to organize and manage multiple tasks in a fast-paced environment • PC literacy required • MS Office skills: Outlook, Word, Excel, and PowerPoint • Excellent verbal and written communication skills • Ability to effectively collaborate in a dynamic environment • May require up to 30% travel

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Voluntary Employee Stock Purchase Plan participation • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits • Reasonable accommodation in the job application process

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