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Remote CSV Lead: GxP Systems & Compliance
Remote / Online - Candidates ideally in
Westborough, Worcester County, Massachusetts, 01581, USA
Listed on 2026-07-10
Westborough, Worcester County, Massachusetts, 01581, USA
Listing for:
Astellas Pharma
Remote/Work from Home
position Listed on 2026-07-10
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Astellas Pharma in Westborough, MA seeks a CSV Lead to develop, execute and maintain the validation strategy for GxP computerized systems supporting manufacturing, laboratory and quality operations. This role ensures compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 while aligning with corporate best practices.
The expert will author and review CSV deliverables, collaborate with cross‑functional teams, and drive continuous validation across upgrades and configurations to ensure data
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