Director, GCP Inspection Management – Americas

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $172 000 - $232 000 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 0%

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BeOne Medicines

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 2010

🧬 Biotechnologie

🏥 Santé

💊 Pharmaceutique

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines est une entreprise mondiale d’oncologie dont le siège est en Suisse. Elle découvre et développe des traitements innovants, plus abordables et plus accessibles aux patients atteints de cancer dans le monde entier. Avec un portefeuille couvrant l’hématologie et les tumeurs solides, BeOne accélère le développement de son pipeline diversifié de nouvelles thérapies grâce à ses capacités internes et à ses collaborations. Forte d’une équipe mondiale en croissance de plus de 11 000 collaborateurs présents sur six continents, l’entreprise s’engage à améliorer radicalement l’accès aux médicaments pour un bien plus grand nombre de patients qui en ont besoin.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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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