Senior QA Leader, Clinical Trials & Compliance

Regulatory Jobs; Center Square (PA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive salary

Health coverage

Pension plans

Life insurance

Wellbeing resources

Training & development

Job summary

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a Senior Manager, Quality Assurance at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

You will lead QA strategy, audits, cross-functional collaboration, and staff mentorship, with travel about 35% as required.

Qualifications

• Bachelor's degree in a relevant discipline.
• 7+ years in QA within the pharmaceutical/biotech/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).
• Excellent analytical and problem-solving skills.
• Exceptional communication and interpersonal skills, with the ability to collaborate across levels.
• Willingness to travel as required (approximately 35%)

Responsibilities

• 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.

Skills

Quality Assurance

Regulatory compliance

Leadership

Analytical thinking

Communication

Travel willingness

Education

Bachelor's degree

Job description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a Senior Manager, Quality Assurance at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

You will lead QA strategy, audits, cross-functional collaboration, and staff mentorship, with travel about 35% as required.