Role description
Job Title
IT Project Manager
Role Summary
The IT Project Manager is responsible for end-to-end delivery of GPM application, data, and integration initiatives, including sustainability/modularization efforts, technical remediation, production releases, webservices, and data archiving.
Key Responsibilities
- Lead planning and execution of IT projects across the full SDLC in accordance with GxP, SDLC governance, validation, and enterprise IT project delivery requirements.
- Own end-to-end IT project management responsibilities, including scope definition, schedule management, resource coordination, dependency tracking, budget awareness, risk management, and delivery oversight.
- Manage project execution using structured project management practices, including project charters, integrated project plans, RAID logs, milestone tracking, status reporting, and stage-gate governance.
- Coordinate cross-functional teams across Business, IT, Quality, Compliance, Validation, Data, Security, Infrastructure, and Vendor partners to ensure aligned delivery of regulated technology initiatives.
- Drive sustainability and modularization efforts to improve long-term maintainability, scalability, operational efficiency, and speed to market.
- Partner with Quality and Compliance teams to ensure releases meet 21 CFR Part 11 requirements, including electronic records, electronic signatures, audit trails, access controls, and system validation expectations.
- Lead delivery of IT initiatives in compliance with GxP regulations, including 21 CFR Part 11, data integrity, computer system validation, change control, release management, and audit-readiness expectations.
- Support regulated environments by embedding quality, validation, and compliance controls across application, data, integration, reporting, and infrastructure initiatives.
- Lead governance cadence, decision forums, steering committee updates, stakeholder communications, executive status reporting, and escalation management.
- Proactively identify project risks, issues, dependencies, and compliance gaps, and drive mitigation plans to ensure timely, controlled, and audit-ready delivery.
- Support vendor coordination, statement-of-work alignment, deliverable tracking, and third-party execution oversight where external partners are involved.
Required Skills & Experience (Enhanced)
- Experience managing IT projects in GxP-regulated environments (pharma, biotech, life sciences, or regulated manufacturing).
- Working knowledge of 21 CFR Part 11, SDLC controls, validation lifecycle, and audit expectations.
- Strong understanding of data integrity principles (ALCOA+), records retention, and compliant data archiving.
- Experience operating within controlled change management and validation governance frameworks.
Skills
project management,computer system validation,change management,it project management,cfr part 11,sdlc,project execution,
About UST
UST is a global digital transformation solutions provider. For more than 20 years, UST has worked side by side with the world’s best companies to make a real impact through transformation. Powered by technology, inspired by people and led by purpose, UST partners with their clients from design to operation. With deep domain expertise and a future-proof philosophy, UST embeds innovation and agility into their clients’ organizations. With over 30,000 employees in 30 countries, UST builds for boundless impact—touching billions of lives in the process.
