Executive Director, Clinical Pharmacology Services, Quality Assurance

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Provides strategic leadership for Quality Assurance (QA) and Regulatory Compliance within the Clinical Pharmacology Services (CPS) division.

• Oversees the design, implementation, and ongoing enhancement of audit, inspection readiness, and quality oversight initiatives throughout CPS.

• Develops and implements the QA strategy for the CPS division.

• Establishes and leads a risk-based quality management review system across CPS operations.

• Creates CPS-specific quality metrics, dashboards, and insights to foster proactive risk identification and ongoing improvement.

• Guarantees consistent interpretation and application of global regulations, including GCP and GMP standards.

• Provides high-level QA oversight for Clinical Pharmacology Units (CPUs), ensuring readiness for inspections and compliance.

• Supervises QA frameworks regulating GMP pharmacy operations within each CPU.

• Promotes standardization and continual enhancement of CPU and GMP pharmacy quality systems.

• Establishes and manages a risk-based quality oversight program for Phase IB/IIA trials.

⛳️ Requirements

• Over 15 years of experience in a regulated clinical trials environment, including senior QA/Regulatory leadership positions.

• Extensive knowledge of GCP and GMP, especially in clinical pharmacology and early-phase settings.

• Bachelor’s degree in Life Sciences (or equivalent experience); advanced degree is preferred.

• Proven track record in defining and executing QA strategies in clinical pharmacology, CPU operations, and GMP-regulated environments.

• Experience managing pharmacy operations that support clinical trials (IP management under GMP).

• Demonstrated success in leading global, matrixed teams.

• Strong executive presence with the capability to influence both internal and external stakeholders.

• Experience in implementing risk-based quality oversight for early-phase trials.

• Solid history of ensuring inspection readiness and engaging with regulatory bodies.

🏝️ Benefits

• Medical

• Dental

• Vision

• Life

• STD/LTD

• 401(K)

• ESPP

• Paid time off (PTO) or Flexible time off (FTO)

• Company bonus where applicable