Director, QA Validation & Computer Systems Assurance

Regeneron · Saratoga Springs

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QualityFull-time$172k–$287kCompany career page

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What they're looking for

BS/BA in Engineering, Computer Science, Life Sciences, or related field; advanced degree preferred
12+ years pharmaceutical or biopharmaceutical manufacturing experience
7+ years validation, computer systems assurance, or quality assurance roles
5+ years people management experience in GxP environment
Direct experience leading CSV or CSA programs for commercial biologics manufacturing
Working knowledge of GAMP 5, FDA 2022 CSA guidance, 21 CFR Part 11, Annex 11, ICH Q9(R1)/Q10
Experience with MES, DCS/SCADA, LIMS, ERP/EBR systems in GMP context

What you'll be doing

Develop and maintain site Validation Master Plan covering process, cleaning, sterilization, utilities, and equipment
Design risk-based qualification programs aligned with FDA, EMA, and ICH guidance for commercial and clinical manufacturing
Lead Computer Systems Assurance program for MES, DCS, LIMS, and software systems using GAMP 5 framework
Establish SDLC framework for GxP-relevant software; oversee vendor assessments and data integrity compliance
Represent and defend validation and CSA programs during FDA, EMA, and other regulatory inspections

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Date posted17 days ago

Last source check1 day ago

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