Executive Director, Clinical Pharmacology Services, Quality Assurance

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🕒 Maio 26

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $220.000 - $245.000 / ano

⏰ Tempo Integral

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

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Fortrea

SiteLinkedInTodas as Vagas

10.000+ funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea é uma organização de pesquisa clínica (CRO) com mais de 30 anos de experiência, dedicada a acelerar o desenvolvimento de tratamentos que mudam vidas ao fornecer soluções clínicas abrangentes para empresas biofarmacêuticas e de MedTech. A empresa oferece uma gama de serviços, incluindo gestão de ensaios clínicos, serviços de farmacologia e estratégia regulatória, todos concebidos de acordo com as necessidades dos clientes. A missão da Fortrea é colocar os pacientes no centro do seu trabalho, buscando levar terapias inovadoras ao mercado mais rapidamente por meio de abordagens personalizadas e orientadas por dados.

Descrição

• Provides executive leadership for Quality Assurance (QA) and Regulatory Compliance within the Clinical Pharmacology Services (CPS) business unit • Leads the design, implementation, and continuous improvement of audit, inspection readiness, and quality oversight programs across CPS • Defines and executes the QA strategy for the CPS business unit • Establishes and leads a risk-based quality management review process across CPS operations • Develops CPS-specific quality metrics, dashboards, and insights to drive proactive risk identification and continuous improvement • Ensures consistent interpretation and application of global regulations, including GCP and GMP requirements • Provides executive QA oversight of Clinical Pharmacology Units (CPUs), ensuring inspection readiness and compliance • Oversees QA frameworks governing GMP pharmacy operations within each CPU • Drives standardization and continuous improvement of CPU and GMP pharmacy quality systems • Establishes and leads a risk-based quality oversight program for Phase IB/IIA trials

🎯 Requisitos

• 15+ years of experience in a clinical trials regulated environment, including senior QA/Regulatory leadership roles • Strong expertise in GCP and GMP, particularly within clinical pharmacology and early-phase environments • Bachelor’s degree in Life Sciences (or equivalent experience); advanced degree preferred • Proven ability to define and execute QA strategies in clinical pharmacology, CPU operations, and GMP-controlled environments • Experience overseeing pharmacy operations supporting clinical trials (IP management under GMP) • Demonstrated success leading global, matrixed teams • Strong executive presence with ability to influence internal and external stakeholders • Experience implementing risk-based quality oversight for early-phase trials • Strong track record in inspection readiness and regulatory engagement

🏖️ Benefícios

• Medical • Dental • Vision • Life • STD/LTD • 401(K) • ESPP • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable