Manager – Plant IT Infrastructure, Operations & GxP Compliance

Position Overview :-

Strategic and hands-on IT leader responsible for managing multi-site GxP-compliant IT operations, plant infrastructure in a regulated pharmaceutical environment. Acts as the SPOC for IT for site leadership, ensuring uptime, compliance, and driving impactful technology-led business enablement.

Experience

9-14 Years in Pharma Plant IT Operations with audit exposure.

Qualification

B.E. / B.Tech / BCA / BCS or an equivalent qualification, combined with relevant pharma IT experience and skillset

RESPONSIBILITIES

GxP IT Operations & Compliance

• Ensure 100% uptime of GxP-critical systems and infrastructure.
• Maintain real-time audit readiness across all sites, manage SOP adherence, QMS notifications, CAPA closure, and periodic reviews.
• Enforce regulatory-compliant practices for user access control, data integrity, and electronic
  records.
• Collaborate with central SAP teams to align plant needs.

IT Infrastructure & Security Management

• Oversee standardization, qualification, AMC, retirement, and reusability of IT assets.
• Implement robust IT security controls, patch management, and cybersecurity governance for both GxP and Non-GxP environments.
• Proactively identify and eliminate CSV bottlenecks affecting manufacturing continuity.

Audit & Regulatory Readiness

• Act as audit-facing SPOC for IT during internal and external audits (MHRA, USFDA, WHO, etc.) as needed.
• Guide and mentor Site IT Leads to take SPOC responsibility at their respective sites, ensuring readiness and compliance.
• Lead pre-audit checks, documentation reviews, and post-audit CAPA implementation.
• Ensure full alignment of IT practices with 21 CFR Part 11, EU Annex 11, and data integrity guidelines.

Project Delivery & Solution Implementation

• Lead IT solution implementation at plant level including POC, vendor coordination, and validation.
• Ensure IT GxP assets and integrations are CSV-validated and fully compliant with GxP requirements across all sites.
• Drive digital transformation and automation initiatives in quality and manufacturing.

Team Leadership & Stakeholder Engagement

• Lead, coach, and upskill a 25+ member IT team (direct/indirect, L2 structure).
• Collaborate with cross-functional teams-Quality, Manufacturing, Engineering, and Projects.
• Conduct regular site leadership connects to align IT strategy with plant KPIs.

IT Governance & AIOps

• Implement AIOps and predictive monitoring to enhance system reliability and automation.
• Define and track IT SLAs, KPIs, and compliance scorecards.
• Drive innovation while ensuring adherence to Unichem and IT Security / InfoSec standards.

Value Addition:

• Proven success in enabling business continuity and audit compliance through IT solutions.
• Spearheaded SAP-integrated projects and AIOps implementation, reducing downtime and manual interventions.
• Delivered cross-site standardization of IT operations, ensuring cost savings and audit consistency.

DESIRED SKILLS

• Deep knowledge of Pharma IT Compliance (GxP, CSV), plant automation systems, and IT infrastructure lifecycle.
• Extensive experience in managing GxP-compliant IT operations at manufacturing sites, with deep understanding of the computerized system validation (CSV) lifecycle and regulatory requirements.
• Excellent leadership, audit-facing, communication, and cross-functional stakeholder management skills.
• SAP certification & relevant IT certifications preferred.
• Strong technical knowledge of SAP systems and IT infrastructure components (networking & server administration).
• Experience in SAP HANA, SAP Fiori, or a similar technology is a plus.
• Excellent problem-solving, analytical, and troubleshooting skills.
• Strong attention to detail with a proactive approach to solving complex technical problems.
• Should have project management experience and familiarity with project management methodologies (Agile, Waterfall, etc.).
• Familiarity with security frameworks and best practices in both SAP and IT infrastructure management.
• Knowledge of system integration techniques between SAP and IT infrastructure.
• Strong communication skills and the ability to interact effectively with technical and non-technical stakeholders.
• Strong leadership and interpersonal skills, with the ability to motivate and manage a multidisciplinary team.
• Willingness to work on diverse projects / areas.
• Strategic thinker with a focus on both operational efficiency and business alignment.
• Strong understanding of cybersecurity principles in plant IT environments, with hands-on experience in monitoring, detecting, and responding to threats to ensure protection against potential cyberattacks.
• Ability to implement and maintain robust security controls for both IT and OT assets in compliance with regulatory and InfoSec standards.