Director, Quality Assurance
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Pennsylvania • United States
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Job Level
Tech Stack
About the role
- Leading the development and implementation of 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.
- Providing expert guidance and support to staff regarding quality assurance policies, procedures, and best practices.
- Contributing to the continuous improvement of quality management systems and documentation.
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with significant experience in a leadership role.
- Extensive knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
- Strong analytical and problem-solving skills, with the ability to identify and resolve complex quality issues.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancecompliance assessmentsauditsquality management systemsregulatory requirementsICH-GCPFDA regulations
Soft Skills
analytical skillsproblem-solving skillscommunication skillsinterpersonal skillscollaboration