Executive Director, Clinical Pharmacology Services, Quality Assurance

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🕒 May 26

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $220k - $245k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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