Senior Manager, Quality Assurance

About the role

ICON Strategic Solutions is hiring a Senior Manager, Quality Assurance in Shanghai. Working in a sponsor-dedicated model, you will ensure the quality and compliance of clinical trials, interpret regulatory requirements and help advance treatments that benefit patients worldwide.

Key responsibilities

• Manage quality assurance and compliance activities across your area so the team meets the highest standards.
• Develop and implement quality assurance strategies and processes supporting clinical trial activities.
• Carry out quality assessments and audits to ensure compliance with regulatory standards and guidelines.
• Work with cross-functional teams to identify quality issues and implement corrective actions.
• Take part in reviewing and approving clinical trial documentation and data for accuracy and completeness.
• Lead and mentor quality assurance staff and foster a culture of continuous improvement.

Required profile

• Bachelor's degree in a relevant discipline.
• At least 7 years of experience in quality assurance within the pharmaceutical, biotechnology or CRO industry, including at least 3 years in a management or leadership role.
• Willingness to travel approximately 35% of the time.
• Legal right to work in the country where the role is based.

Required skills

• Strong knowledge of regulatory requirements for clinical trials, such as ICH-GCP and FDA regulations.
• Excellent analytical and problem-solving skills.
• Exceptional communication and interpersonal skills.

What we offer

• 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 learning and development opportunities.