IT Manufacturing Lead - Pune

Position Overview:

Key Responsibilities:

• Lead the management, maintenance, and enhancement of GMP IT enterprise applications including but not limited to QMS, MES, Logbook, Track and Trace, DMS, and LIMS.
• Oversee Operational Technology (OT) systems supporting pharmaceutical manufacturing and quality operations globally.
• Drive Collaborative initiatives within GXP Process and be a catalyst to drive digitization within the shopfloor by coordinating with Business stakeholders within Quality, Manufacturing, Compliance, and IT teams to align IT initiatives with business and regulatory needs.
• Ensure all IT systems comply with relevant pharmaceutical regulatory requirements (e.g., FDA 21 CFR Part 11, EU GMP Annex 11).
• Develop and implement Computer System Validation (CSV) strategies and execution plans for new and existing systems.
• Manage vendor relationships and coordinate third-party audits and validations from an IT and CSV perspective.
• Lead cross-functional teams in system upgrades, implementations, and lifecycle management activities for all GXP systems.
• Drive continuous improvement and digital transformation projects to enhance system capabilities and user experience.
• Develop and deliver training and documentation to ensure user competence and system adherence.
• Monitor system performance, risk management, and incident resolution processes.

Qualifications:

• Bachelors or Master’s degree in Information Technology, Computer Science, Engineering, or related field.
• 10 plus years of progressive IT experience within the pharmaceutical or life sciences industry, with significant exposure to OT and CSV.
• In-depth knowledge and hands-on experience managing GMP enterprise IT applications such as QMS, Track and Trace, DMS, and LIMS.
• Proven expertise in Computer System Validation (CSV) methodologies and regulatory requirements (FDA, EMA, PIC/S).
• Strong understanding of pharmaceutical manufacturing processes and quality systems.
• Experience managing Operational Technology (OT) environments including SCADA, MES, and related automation systems.
• Excellent project management, leadership, and communication skills.
• Ability to work effectively in a global, matrixed environment.