Clinical Quality Compliance Lead

FSP-Clinical Quality Complaince Lead- Client office based with flexible WFH

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

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.

What You Will Do:

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

Key responsibilities include:

• 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.

Your Profile:

You will have solid quality assurance and compliance experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• 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.
• At least 5 years CRA experience
• Nice to have 3 years above project management, Principle CRA, Lead CRA or Qualify Management experience.
• Willingness to travel as required (approximately 15%)

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply