Senior Clinical QA & Compliance Lead

IRE; United States; Remote; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health and wellbeing programmes

Life assurance and disability coverage

Learning and development opportunities

Job summary

ICON, a global healthcare intelligence and clinical research organisation, seeks a Clinical Quality Compliance Manager to oversee clinical trial quality at country and site levels. You will apply a risk-based approach to identify, evaluate, and manage compliance risks, ensuring GCP adherence, company procedures, and regulatory requirements.

In this role you will coordinate QA delivery, resolve issues, and build team capability while collaborating with cross-functional teams to safeguard patient

Qualifications

• Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry.
• Knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
• Excellent communication and interpersonal skills and ability to collaborate with cross-functional teams.
• Willingness to travel approximately 35%.

Responsibilities

• Developing and implementing quality assurance strategies and processes to support clinical trial activities.
• Conducting quality assessments and audits to ensure compliance with regulatory standards and guidelines.
• Collaborating with project teams to identify and address quality issues and implement corrective actions as needed.
• Providing guidance and support to staff regarding quality assurance policies, procedures, and best practices.
• Contributing to the development and maintenance of quality management systems and documentation.

Skills

Quality assurance

Regulatory knowledge

Analytical skills

Communication skills

Travel willingness

Education

Bachelor's degree in a relevant discipline

Job description

ICON, a global healthcare intelligence and clinical research organisation, seeks a Clinical Quality Compliance Manager to oversee clinical trial quality at country and site levels. You will apply a risk-based approach to identify, evaluate, and manage compliance risks, ensuring GCP adherence, company procedures, and regulatory requirements.

In this role you will coordinate QA delivery, resolve issues, and build team capability while collaborating with cross-functional teams to safeguard patient