GxP IT Project Manager

Xinthe Technologies; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Xinthe Technologies is seeking an IT Project Manager to oversee end-to-end delivery of GPM application, data and integration initiatives, ensuring compliance with 21 CFR Part 11 and SDLC governance. You will drive planning, tracking, and risk mitigation across cross-functional teams.

Responsibilities include managing regulated projects, enforcing data integrity (ALCOA+), archival initiatives, and governance cadences with stakeholders. Strong domain knowledge in pharma/biotech is required.

Qualifications

• Experience managing IT projects in GxP-regulated environments.
• Knowledge of 21 CFR Part 11, validation lifecycle, and audit trails.
• Strong data integrity, records retention, and compliant data archiving.
• Experience with controlled change management and validation governance.

Responsibilities

• Plan and execute GPM projects across the full SDLC per governance.
• Lead sustainability and modularization to improve maintainability and speed.
• Coordinate with Quality and Compliance for compliant releases.
• Ensure integrations and webservices meet data integrity, security, traceability.
• Deliver initiatives with validation and audit-readiness.
• Embed quality controls across application, data, integration.
• Maintain integrated project plans and milestone tracking.
• Oversee data archiving aligned with records retention.
• Manage cross-team impacts from data changes and upgrades.
• Lead governance cadence and stakeholder communications.

Skills

GxP regulated IT projects

21 CFR Part 11 compliance

Data integrity ALCOA+

SDLC governance

Job description

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.
• Strong 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 offshore delivery models.
• Understanding of data migration, integration, and scheduling algorithms.