Senior Manager, Quality Assurance

Regulatory Jobs; Center Square (PA); Sur place; USD 120 000 - 190 000; Plein temps

Avantages offerts par ce poste

Health & wellbeing

Retirement plans

Life assurance

Employee assistance

Training & career pathways

Competitive compensation

Résumé du poste

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%.

Responsabilités

• 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.

Connaissances

Quality assurance

Regulatory compliance

Leadership

Analytical thinking

Communication

Travel readiness

Formation

Bachelor's degree in a relevant discipline

Description du poste

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.

Visit our careers site to read more about the benefits ICON offers.

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.