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

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

Executive Director, Clinical Pharmacology Services, Quality Assurance

Key skills