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:
- planning and execution of GPM projects across the full SDLC in accordance with GxP and SDLC governance requirements.
- GPM sustainability and modularization efforts to improve long-term maintainability and speed to market.
- Partner with Quality and Compliance teams to ensure releases meet 21 CFR Part 11 requirements (electronic records, audit trails, access controls).
- Ensure integrations and webservices comply with GxP data integrity, security, and traceability requirements.
- Delivery of GPM initiatives in compliance with GxP regulations, including 21 CFR Part 11, data integrity, validation, and audit-readiness expectations.
- Support regulated environments by embedding quality, validation, and compliance controls across application, data, and integration initiatives.
- Maintain integrated project plans, RAID logs,



and milestone tracking.
- data archiving initiatives align with GxP records retention, data integrity, and regulatory requirements.
- Manage cross-team impacts related to data changes, archiving, and system upgrades.
- Lead governance cadence, decision forums, and stakeholder communications.

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.
- Robust understanding of data integrity principles (ALCOA+), records retention, and compliant data archiving.
- Experience operating within controlled change management and validation governance frameworks.

Good-to-Have Skills
- Experience in Life Sciences, Pharma, or Manufacturing sectors.
- Exposure to global vendor management and offsho

📌 GxP IT Project Manager (Hyderabad)
🏢 Xinthe Technologies
📍 Hyderabad