Job Title: IT Deputy Manager / Manager – Infrastructure, Compliance & Validation
Department: Information Technology
Experience: 12–15+ Years
Industry Preference: Pharmaceutical, Life Sciences, Biotechnology, CRO/CDMO, or Regulated Manufacturing
Job Summary
We are seeking an experienced IT Deputy Manager / Manager to lead and manage enterprise IT infrastructure, cybersecurity, regulated systems, and compliance activities within a GMP-regulated pharmaceutical environment. The ideal candidate should possess strong expertise in IT operations, Computer System Validation (CSV), regulatory compliance, and pharmaceutical application support while ensuring high availability, security, and compliance of IT systems.
Key Responsibilities
IT Infrastructure & Operations
- Manage and maintain Windows/Linux servers, Active Directory, virtualization platforms, storage systems, and cloud infrastructure.
- Oversee network administration, including Firewalls, VPN, LAN/WAN, SD-WAN, and cybersecurity controls.
- Ensure high availability of business-critical systems through proactive monitoring and maintenance.
- Manage IT service delivery, incident management, problem management, and change management processes.
- Develop and implement IT policies, SOPs, and best practices.
Backup, Disaster Recovery & Business Continuity
- Establish and maintain backup, disaster recovery, and business continuity strategies.
- Conduct periodic disaster recovery testing and ensure compliance with business continuity requirements.
- Monitor backup infrastructure and ensure data protection standards are maintained.
GMP, GxP & Regulatory Compliance
- Ensure compliance with GMP, GxP, Data Integrity (ALCOA+), 21 CFR Part 11, Annex 11, and GAMP 5 requirements.
- Support regulatory inspections, customer audits, and internal quality audits.
- Maintain compliance documentation, periodic reviews, and audit readiness of computerized systems.
Computer System Validation (CSV)
- Manage the complete CSV lifecycle, including URS, Risk Assessments, IQ, OQ, PQ, Traceability Matrix, and Validation Reports.
- Ensure risk-based validation approaches and change control processes are effectively implemented.
- Review and approve validation documentation and compliance assessments.
Pharmaceutical Systems Support
- Support and administer regulated applications such as LIMS, MES, QMS, ERP (SAP), EDMS, ELN, and other GxP systems.
- Collaborate with Quality, Manufacturing, Engineering, and Laboratory teams to ensure uninterrupted operations.
- Manage system upgrades, integrations, and vendor coordination activities.
Leadership & Project Management
- Lead and mentor IT teams, vendors, and cross-functional stakeholders.
- Drive IT infrastructure, digital transformation, and compliance-related projects.
- Manage project timelines, budgets, resources, and risk mitigation activities.
- Establish performance metrics and continuous improvement initiatives.
Required Qualifications
- Bachelor's or Master's Degree in Computer Science, Information Technology, Engineering, or related discipline.
- 12–15+ years of IT experience, preferably in pharmaceutical, life sciences, or regulated manufacturing environments.
- Strong knowledge of IT infrastructure, networking, cybersecurity, and cloud technologies.
- Hands-on experience with GMP/GxP compliance and Computer System Validation.
- Experience supporting regulatory audits and inspections.
- Excellent leadership, communication, stakeholder management, and project management skills.
Preferred Skills
- Experience with SAP, LIMS, MES, QMS, EDMS, ELN, and other validated systems.
- Knowledge of cybersecurity frameworks and risk management.
- Certifications such as ITIL, PMP, CISSP, VMware, Microsoft, or relevant validation/compliance certifications will be an added advantage.
