Job Title

Job description The IT Manager will be responsible for overseeing all IT operations within the pharmaceutical company, ensuring seamless functioning of IT infrastructure, data security, compliance with pharma industry regulations, and implementation of digital solutions to support manufacturing, quality, R&D, and commercial operations. The role involves managing IT teams, vendors, and projects while ensuring systems align with business objectives and regulatory guidelines (21 CFR Part 11, GxP, Data Integrity). Key Responsibilities - IT Infrastructure & Operations - Oversee day-to-day IT operations including servers, networks, ERP (SAP/Oracle), LIMS, DMS, and MES systems. - Ensure system uptime, disaster recovery, and business continuity planning. - Manage hardware, software, licensing, and IT asset inventory. - Pharma Regulatory Compliance - Ensure IT systems comply with regulatory requirements such as USFDA, EMA, MHRA, WHO, and other guidelines. - Implement and maintain 21 CFR Part 11 compliance for electronic records and signatures. - Support validation of computerized systems (CSV) as per GxP guidelines. - Cybersecurity & Data Management - Implement IT security policies, firewalls, and data protection measures. - Safeguard sensitive data including clinical data, manufacturing batch records, and HR information. - Regularly conduct IT audits and risk assessments. - Team & Vendor Management - Lead, train, and mentor the IT support team. - Coordinate with external vendors, consultants, and technology partners for software/hardware implementation. - Manage IT budgets, procurement, and cost optimization initiatives. - Digital Transformation & Innovation - Drive automation and digitalization in pharma operations (e.g., paperless QMS, e-logbooks). - Support R&D, QA/QC labs, and production units with IT-enabled solutions. - Evaluate and implement new technologies like cloud solutions, AI, and data analytics. Qualifications & Skills - Bachelors / Masters in Information Technology, Computer Science, or related field. - 8-12 years of IT experience with at least 35 years in a managerial role in the pharmaceutical industry. - Strong knowledge of ERP (SAP/Oracle), LIMS, QMS, MES, DMS, CSV, and GxP guidelines. - Hands-on experience in networking, servers, cloud computing, cybersecurity, and data integrity compliance. - Familiarity with 21 CFR Part 11, EU Annex 11, and pharma regulatory audits. - Excellent leadership, problem-solving, and vendor negotiation skills. - Strong communication skills to work with cross-functional teams (QA, QC, Production, R&D, Regulatory). Key Competencies - Regulatory compliance mindset (USFDA, EMA, WHO). - IT project management and digital transformation skills. - Ability to troubleshoot and resolve critical IT issues under pressure. - Strong stakeholder management and decision-making abilities.