Clinical Quality Compliance Lead

Icon Plc • Blue Bell, PA

49d

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. We are currently seeking a Clinical Quality Compliance Lead to join our diverse and dynamic team. As a Clinical Quality Compliance Lead at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

Requirements

• 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.

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.

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 5,001-10,000 employees