Director of Quality jobs in United States
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Green Life Science · 6 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.

Staffing & Recruiting
Hiring Manager
Charles Robinson
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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

FDA regulationsICH/GCP guidelinesClinical trial complianceAudits managementCAPA programsLeadership skillsTeam management

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

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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 Stage
Company data provided by crunchbase