Vice President – Clinical Quality Assurance

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🕒 Julho 17

🎸 Tennessee – Remoto

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⏰ Tempo Integral

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

🦅 Patrocina Visto H1B

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👻 Score fantasma 47%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of McKesson

McKesson

10.000+ funcionários

Fundada em 1833

💼 Consultoria

📦 Logística

🏥 Saúde

Consulting • Logistics • Healthcare

A McKesson é uma líder diversificada em saúde, especializada em distribuição farmacêutica, suprimentos médicos e serviços de saúde. Suas soluções facilitam o acesso de pacientes a terapias transformadoras, apoiam operações eficientes para farmácias, sistemas de saúde e clínicas, e abordam questões críticas como a escassez de medicamentos por meio de uma cadeia de suprimentos resiliente. A McKesson oferece serviços abrangentes como software de gestão de farmácias, consultoria e soluções tecnológicas para práticas especializadas, focando em melhorar os resultados de saúde e promover a indústria farmacêutica. Eles trabalham em estreita colaboração com empresas biofarmacêuticas para melhorar o acesso a medicamentos, adesão e comercialização, enquanto apoiam práticas oncológicas e biofarmacêuticas por meio de insights orientados por dados e evidências do mundo real.

Descrição

• Serve as the organization's highest-ranking Quality leader, reporting directly to the Chief Executive Officer • Provide strategic leadership and operational oversight for SCRI's Quality Management System • Drive a culture of quality and continuous improvement across the organization • Maintain ongoing inspection readiness and advance quality initiatives supporting operational excellence and organizational growth • Provide senior Quality leadership and operational direction across SCRI • Lead, develop, and mentor the Quality Assurance team • Establish goals, performance expectations, and development plans for Quality staff • Partner with executive leadership and stakeholders on quality, compliance, and risk management • Maintain, optimize, and continuously improve the Quality Management System • Oversee policies, procedures, training, documentation practices, and quality oversight activities • Oversee audits, inspections, CAPA, deviations, investigations, and quality metrics • Use trend analysis and risk evaluation to resolve quality issues • Drive best practices, change management, and cross-functional engagement • Manage departmental priorities, budgets, and resource allocation

🎯 Requisitos

• Progressive Quality Assurance, Quality Management, or compliance leadership experience in regulated healthcare, clinical research, life sciences, or similar industries • Experience managing Quality Management Systems, including audits, inspections, CAPA, deviations, change control, training, and quality metrics • Proven success leading teams, partnering across functions, and driving quality, operational improvements, and business results • Extensive knowledge of FDA guidelines, GCP, applicable regulations, Quality and Clinical IT Systems and experience • Knowledge of medical and clinical research terminology • Thorough understanding of investigative site research requirements, quality metrics, and performance measures • 7+ years' experience interpreting and applying regulatory requirements, translating them to operational practice, and providing practical guidance to leadership and cross-functional business partners • Highly effective ability to engage with senior leaders, regulators, auditors, and internal stakeholders on quality and compliance matters • Bachelor's Degree required • RAPS - Regulatory Affairs Certification highly preferred • Master's Degree preferred

🏖️ Benefícios

• Comprehensive Total Rewards package supporting physical, mental, and financial well-being • Annual bonus or long-term incentive opportunities may be offered • Relocation assistance is not available • Visa sponsorship is not available

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