Director, GCP Inspection Management – Americas

🕒 Outubro 9

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $172.000 - $232.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 1%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 35 dias.
• As vagas desta empresa costumam ser preenchidas em 41 dias.

Candidatar-se

Adaptar currículo + carta de apresentação

Encontrar Vagas Remotas Similares

☆ Salvar☑️ Marcar como candidatado❌ Ocultar

Reportar problema

BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

Biotechnology • Healthcare • Pharmaceuticals

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo