Senior Manager, Quality Assurance

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

Senior Manager, Quality Assurance

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 values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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%)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

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.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a requesthere.