Sr. Manager, Clinical Compliance

ICON plc

2d

About The Position

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 Senior Manager, Quality Assurance at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

Requirements

• Bachelor's degree in a relevant discipline
• Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a management or leadership role.
• Strong knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
• Excellent analytical and problem-solving skills, with the ability to identify and resolve complex quality issues.
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively with colleagues and stakeholders at all levels.
• Willingness to travel as required (approximately 35%)

Responsibilities

• Manage quality assurance and compliance activities across your area, ensuring your team delivers to the highest standards.
• Developing and implementing quality assurance strategies and processes to support clinical trial activities.
• Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines.
• Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed.
• Participating in the review and approval of clinical trial documentation and data to ensure accuracy and completeness.
• Providing leadership and mentorship to quality assurance staff, fostering a culture of excellence and continuous improvement.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager