Job
Description
As the Strategic and hands-on IT leader responsible for managing multi-site GxP-compliant IT operations and plant infrastructure in a regulated pharmaceutical environment, your role will be pivotal in ensuring uptime, compliance, and driving impactful technology-led business enablement. You will act as the Single Point of Contact (SPOC) for IT for site leadership, maintaining real-time audit readiness, enforcing regulatory-compliant practices, and collaborating with central SAP teams to align plant needs. With 9-14 years of experience in Pharma Plant IT Operations and audit exposure, along with a qualification in B.E. / B.Tech / BCA / BCS or an equivalent qualification, you will be expected to fulfill the following responsibilities: GxP IT Operations & Compliance: - Ensure 100% uptime of GxP-critical systems and infrastructure. - Maintain real-time audit readiness, 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. - Identify and eliminate CSV bottlenecks affecting manufacturing continuity. Audit & Regulatory Readiness: - Act as audit-facing SPOC for IT during internal and external audits. - Guide Site IT Leads to ensure readiness and compliance. - Lead pre-audit checks, documentation reviews, and post-audit CAPA implementation. - Ensure full alignment of IT practices with regulatory guidelines. Project Delivery & Solution Implementation: - Lead IT solution implementation at plant level. - Ensure IT assets and integrations are fully compliant with GxP requirements. - Drive digital transformation and automation initiatives. Team Leadership & Stakeholder Engagement: - Lead, coach, and upskill a 25+ member IT team. - Collaborate with Quality, Manufacturing, Engineering, and Projects teams. - Align IT strategy with plant KPIs. IT Governance & AIOps: - Implement AIOps and predictive monitoring for system reliability. - Define and track IT SLAs, KPIs, and compliance scorecards. - Drive innovation while ensuring adherence to IT Security standards. Value Addition: - Proven success in business continuity and audit compliance through IT solutions. - Spearheaded SAP-integrated projects and AIOps implementation. - Delivered cross-site standardization of IT operations. Desired Skills: - Deep knowledge of Pharma IT Compliance, plant automation systems, and IT infrastructure lifecycle. - Strong leadership, audit-facing, communication, and stakeholder management skills. - SAP certification & relevant IT certifications preferred. - Technical knowledge of SAP systems and IT infrastructure components. - Experience in SAP HANA, SAP Fiori, or similar technology is a plus. - Strong problem-solving, analytical, and troubleshooting skills. - Project management experience with familiarity in Agile and Waterfall methodologies. - Familiarity with security frameworks in SAP and IT infrastructure management. - Strong understanding of cybersecurity principles in plant IT environments. Your role will require a strategic mindset focused on operational efficiency and business alignment, along with the ability to lead a multidisciplinary team effectively and ensure compliance with regulatory and InfoSec standards.,
