Senior Director, Global Quality & Compliance

Worldwide Clinical Trials; United Kingdom; On-site; GBP 95,000 - 160,000; Full time

Job summary

Worldwide Clinical Trials is a global midsize CRO seeking a strategic Quality Leader to drive regulatory compliance, quality governance, and inspection readiness across all clinical research services. You will lead a team of QA professionals, collaborate with executives, and support audit readiness for sponsors and regulatory bodies.

The role requires extensive experience with ICH-GCP, FDA/EMA/MHRA guidelines, and CRO operations, with a focus on enterprise risk management and governance.

Qualifications

• Extensive knowledge of global regulatory requirements (ICH-GCP, FDA, EMA, MHRA).
• Experience leading quality and regulatory compliance in CRO/pharma settings.
• Strong governance, risk management, and inspection readiness capabilities.

Responsibilities

• Develop and execute global quality and compliance strategy.
• Provide leadership for QA across clinical research services.
• Lead quality maturity initiatives to enhance operational effectiveness.
• Manage senior quality representation for clients and partners.
• Oversee Quality Management System governance and CAPA processes.
• Present metrics and trends to stakeholders and executives.
• Support regulatory inspections and sponsor audits.
• Guide risk assessment and mitigation across functions.

Skills

ICH-GCP compliance

FDA regulations

EMA guidance

MHRA requirements

Quality management systems

Inspection readiness

Risk management

Regulatory strategy

Leadership

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, Quality, Regulatory Affairs, or related scientific discipline

Advanced degree (MSc, PharmD, PhD, MBA)

Job description

Worldwide Clinical Trials is a global midsize CRO seeking a strategic Quality Leader to drive regulatory compliance, quality governance, and inspection readiness across all clinical research services. You will lead a team of QA professionals, collaborate with executives, and support audit readiness for sponsors and regulatory bodies.

The role requires extensive experience with ICH-GCP, FDA/EMA/MHRA guidelines, and CRO operations, with a focus on enterprise risk management and governance.