IT Project Manager – GMP Applications (SEEQ & Statistica Upgrade)
Full-time Mid-Senior LevelJob Overview
We are seeking an experienced IT Project Manager with deep GxP and validation expertise to lead the upgrade of SEEQ and Statistica - critical GMP-compliant analytics tools used in manufacturing and process environments. The role requires strong coordination across IT, QA, process engineering, vendors, and data teams.
Key Responsibilities:
- Lead GMP application upgrades (SEEQ & Statistica) with full validation lifecycle (CSV/CSA)
- Coordinate vendor delivery ensuring compliance with validation, cybersecurity, and documentation standards
- Drive cross-functional collaboration across QA, Process Owners, Digital/Data, and IT Compliance
- Develop and manage validation plans, testing, traceability, risk assessments, and release documentation
- Maintain RAID logs, lead risk workshops, and manage change control and cutover plans
- Ensure strict adherence to 21 CFR Part 11, Annex 11, and ALCOA+ principles
- Manage multi-site/staged deployments in a regulated manufacturing setting
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