Senior Quality Assurance Manager, Clinical Trials

Regulatory Jobs; Center Square (PA); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Health & wellbeing

Retirement plans

Life assurance

Employee assistance

Training & career pathways

Competitive compensation

Job summary

ICON is a global healthcare intelligence and clinical research organization committed to bringing new medicines to patients faster. The Senior Manager, Quality Assurance will lead QA across the clinical program, ensuring regulatory compliance and data integrity.

You will develop QA strategies, conduct audits, mentor staff, and collaborate with cross-functional teams to drive continuous improvement and ensure trial readiness worldwide.

Qualifications

• Bachelor's degree in a relevant discipline.
• 7+ years of experience in quality assurance within the pharmaceutical, biotech, or CRO industry.
• At least 3 years in a management or leadership role.
• Strong knowledge of regulatory requirements and guidelines (ICH-GCP, FDA).
• Excellent analytical and problem-solving skills.
• Excellent communication and interpersonal skills; travel approximately 35%.

Responsibilities

• Developing and implementing quality assurance strategies to support clinical trial activities.
• Conducting quality assessments and audits to ensure regulatory compliance.
• Collaborating with cross-functional teams to address quality issues and implement corrective actions.
• Participating in review and approval of clinical trial documentation and data.
• Providing leadership and mentorship to QA staff to drive continuous improvement.

Skills

Quality assurance

Regulatory compliance

Leadership

Analytical thinking

Communication

Travel readiness

Education

Bachelor's degree in a relevant discipline

Job description

ICON is a global healthcare intelligence and clinical research organization committed to bringing new medicines to patients faster. The Senior Manager, Quality Assurance will lead QA across the clinical program, ensuring regulatory compliance and data integrity.

You will develop QA strategies, conduct audits, mentor staff, and collaborate with cross-functional teams to drive continuous improvement and ensure trial readiness worldwide.