[Hiring] Clinical Quality Compliance Lead @ICON plc

Role Description

As a Clinical Quality Compliance Lead at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

You will oversee quality assurance and compliance workstreams, ensuring deliverables meet quality and timeline expectations.

• 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.

Qualifications

• 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 effectively prioritize tasks and manage resources to meet objectives.
• Excellent communication, interpersonal, and problem-solving skills, with the ability to influence and collaborate with stakeholders at all levels of the organization.
• Willingness to travel as required (approximately 65%).

Requirements

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• 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.
• Benefits may vary depending on role and location.