Senior Manager, Quality Assurance

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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.

What You Will Do:

You will manage quality assurance and compliance activities across your area, ensuring your team delivers to the highest standards. Key responsibilities include:

• 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.

Your Profile:

You will have a strong background in quality assurance and compliance, with proven management experience and a commitment to quality delivery. Required qualifications and experience:

• 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%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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.