Executive QA Leader, Clinical Pharmacology & Early-Phase

Fortrea; Ledston; On-site; GBP 150,000 - 190,000; Full time

Job summary

Fortrea in Leeds, United Kingdom, seeks an executive QA leader to drive quality strategy across Clinical Pharmacology Units, GMP pharmacy operations, and early-phase programs. You will lead risk-based oversight, ensure inspection readiness, and champion a culture of quality and regulatory excellence.

You will collaborate with Clinical Operations, Medical, and Safety to align quality governance with CPS delivery, while guiding global teams and stakeholders through continuous improvement

Qualifications

• Extensive 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; advanced degree preferred. Equivalent experience may be considered.

Responsibilities

• Provide executive QA leadership for CPS, ensuring inspection readiness and compliance with GCP, GMP, and regulatory standards.
• Oversee QA frameworks for GMP pharmacy operations within CPUs, including IP handling, labeling, storage and accountability.
• Lead risk-based quality oversight for Phase IB/IIA trials outside CPS clinics with decentralized/early-phase models.
• Drive standardization and continuous improvement of CPU and GMP pharmacy quality systems across global sites.
• Embed quality-by-design principles into early-phase program design and execution.
• Partner with stakeholders to manage QA budgets and ensure timely delivery of services.

Skills

QA strategy

GCP & GMP

Regulatory leadership

Executive presence

Stakeholder engagement

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred

Job description

Fortrea in Leeds, United Kingdom, seeks an executive QA leader to drive quality strategy across Clinical Pharmacology Units, GMP pharmacy operations, and early-phase programs. You will lead risk-based oversight, ensure inspection readiness, and champion a culture of quality and regulatory excellence.

You will collaborate with Clinical Operations, Medical, and Safety to align quality governance with CPS delivery, while guiding global teams and stakeholders through continuous improvement