Clinical Quality Compliance Lead

About the role

At ICON Strategic Solutions, you will work in a sponsor‑dedicated model, supported by ICON’s global expertise. As a Clinical Quality Compliance Lead, you will design and analyse clinical trials, interpret complex medical data, and contribute to the advancement of innovative treatments and therapies.

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 and ensure timely resolution.
• Conduct regular quality reviews of clinical trial documentation, protocols, and study reports, identifying areas for improvement and implementing corrective actions as necessary.
• 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 risk mitigation strategies, and drive continuous improvement initiatives.

Required profile

• Solid quality assurance and compliance experience, with the ability to manage competing priorities and develop your team.
• Bachelor's degree or higher in a relevant scientific discipline or healthcare‑related field.
• Previous experience in clinical quality assurance or compliance within the pharmaceutical, biotechnology, or CRO industry.
• Expert knowledge of regulatory requirements, including FDA/EMA regulations, ICH‑GCP guidelines, and ISO standards.
• Strong leadership and project management skills, with the ability to prioritize tasks and manage resources.
• Excellent communication, interpersonal, and problem‑solving skills, with the ability to influence and collaborate with stakeholders at all levels.
• Willingness to travel as required (approximately 65%).

What we offer

• Competitive salary and various annual leave entitlements.
• Health insurance offerings for you and your family.
• Competitive retirement planning options.
• Global Employee Assistance Programme (LifeWorks) providing 24‑hour access to professional support.
• Life assurance and flexible country‑specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, and health assessments.