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  5. Senior Director, Quality & Compliance

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Himalayas

Senior Director, Quality & Compliance

United StatesPosted 2 days agoVerified 1 day ago

About This Gig

Position Summary: The Senior Director, Quality & Compliance provides strategic and operational leadership for clinical quality assurance to ensure studies are planned, conducted, documented, and reported in compliance with applicable global regulations (e.g., ICH E6 GCP), sponsor requirements, and Precision procedures. This role leads the design, implementation, and continuous improvement of GCP-focused quality systems and oversight activities, including risk-based audit programs (sites, vendors, internal process, and TMF), issue management (deviations, quality events, and CAPA), inspection readiness, and support of health authority and Sponsor audits/inspections. Partnering cross-functionally with Operations and other stakeholders, the Senior Director proactively identifies and mitigates quality and compliance risks, drives a culture of quality and data integrity, and develops and mentors QA professionals while serving as a trusted advisor to internal teams and external clients.

Skills & Tags

DeveloperQuality AssuranceClinical Research& ComplianceRegulatory AffairsClinical Quality Assurance

About the Seller

P

Precision Medicine Group

on Himalayas

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