Green Life Science · 8 hours ago
Director of Quality
Green Life Science is a leading U.S.-based clinical research organization seeking an experienced Quality Assurance & Compliance Director to oversee QA operations at one of their key clinical sites. The role involves leading audits, managing QA/QC staff, and supporting quality initiatives across multiple clinical sites.
Responsibilities
Lead and conduct audits of clinical trial documents, Case Report Forms, and Clinical Study Reports to ensure compliance with FDA regulations, GCP, and internal SOPs
Manage and mentor QA/QC staff, ensuring training completion and adherence to quality standards
Facilitate Sponsor audits, regulatory inspections, and CAPA investigations, resolving compliance issues promptly
Support quality initiatives across multiple clinical sites and strengthen the company-wide Quality Management System (QMS)
Supervise and guide QA/QC staff in alignment with organizational compliance goals
Qualification
Required
10+ years' experience in clinical research, pharmaceutical, or medical device industries
Strong knowledge of FDA regulations, ICH/GCP guidelines, and clinical trial compliance
Extensive experience managing audits and CAPA programs
Proven leadership and team management skills
Ability to travel and relocate as required to support multiple sites
Benefits
Competitive benefits
401(k) match
Paid time off
Company
Green Life Science
Green Life Science | Putting the ‘Search’ into Research At Green Life Science we are a specialist executive search partner within Life Sciences.
Funding
Current Stage
Early StageCompany data provided by crunchbase