Clinical Quality Compliance Lead

About the role

ICON is seeking a Clinical Quality Compliance Lead to join its sponsor‑dedicated model. You will design and analyse clinical trials, interpret complex medical data, and help advance innovative treatments that benefit patients worldwide.

Key responsibilities

• Develop and implement comprehensive quality management systems and processes to ensure compliance with regulatory requirements, industry standards, and company policies.
• Lead internal and external audits and inspections, including planning, execution, and follow‑up activities to address findings.
• Conduct regular quality reviews of clinical trial documentation, protocols, and study reports, identifying improvement areas and implementing corrective actions.
• Provide leadership and guidance to the clinical quality compliance team, including training, mentoring, and performance management.
• Collaborate with cross‑functional teams to assess quality risks, develop mitigation strategies, and drive continuous improvement initiatives.

Required profile

• Bachelor's degree or higher in a relevant scientific or healthcare‑related field.
• Previous experience in clinical quality assurance or compliance within the pharmaceutical, biotechnology, or CRO industry.
• Strong leadership and project management skills with the ability to prioritize tasks and manage resources.
• Excellent communication, interpersonal, and problem‑solving abilities.
• Willingness to travel approximately 65% as required.

Required skills

• Expert knowledge of FDA/EMA regulatory requirements.
• Familiarity with ICH‑GCP guidelines.
• Understanding of ISO standards related to clinical quality.

What we offer

• Competitive base salary and performance‑related incentives.
• Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.