senior mana

Encube Ethicals; Mumbai; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Encube Ethicals in Mumbai seeks a Senior Manager – IT Infrastructure & Security to lead IT infrastructure, cybersecurity, information security and IT compliance across HO, R&D and manufacturing plants. The role ensures a secure, reliable, scalable and compliant IT environment while managing budgets, vendors and audit readiness.

The candidate should have 15–20 years of IT experience in pharma/GxP, with CSV, GAMP 5, FDA 21 CFR Part 11 and EU GMP Annex 11 exposure, and proven leadership across

Qualifications

• B.E./B.Tech in Computer Science / IT / Electronics Engineering mandatory.
• 15–20 years of IT experience in pharmaceutical or life sciences.
• Strong exposure to CSV, GAMP 5, 21 CFR Part 11 and EU GMP Annex 11.
• Experience across IT infrastructure, cybersecurity, and regulatory audits.
• Leadership of multi-site IT teams and vendor management.

Responsibilities

• Lead end-to-end IT infrastructure and operations across HO, R&D and plants.
• Oversee cybersecurity governance, ISO 27001 / NIST CSF controls and incident response.
• Ensure GxP IT compliance and CSV-related validation activities.
• Manage IAM, backup, DR and DR drills with defined RTO/RPO.
• Partner with auditors during FDA/WHO-GMP inspections and audits.

Skills

IT Infrastructure

Cybersecurity

Regulatory Compliance

GxP IT

Vendor Management

ISO 27001

Cloud (Azure/AWS)

VMware/Hyper-V

SIEM/SOC

CSV & Validation

Education

BE/B.Tech in CS/IT/Electronics

M.Tech / MBA in IT

Tools

ServiceNow

SAP S/4HANA

SAP Business One

DR & Backup tools

ITSM tools

Job description

Senior Manager IT Infrastructure & Security

Department: Information Technology
Location: HO Andheri, Mumbai
Experience: 15–20 Years
Qualification: B.E./B.Tech in Computer Science, IT or Electronics Engineering – Mandatory
Reporting To: Head – IT & Innovation

Role Overview

We are looking for an experienced Senior Manager – IT Infrastructure & Security to lead IT infrastructure, cybersecurity, information security, and IT compliance across the organization's Head Office, R&D and manufacturing plants.

The role will be responsible for ensuring a secure, reliable, scalable and compliant IT environment, while managing infrastructure operations, cybersecurity, disaster recovery, vendors, budgets, team performance and regulatory audit readiness.

The candidate must have strong experience in a pharmaceutical/GxP environment with practical exposure to CSV, GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11 and ALCOA+ data integrity requirements.

Key Responsibilities

IT Infrastructure & Operations

• Lead end-to-end IT infrastructure management across HO, R&D, plants and other locations.
• Manage data centers, servers, storage, virtualization, LAN/WAN, SD-WAN, MPLS, Wi-Fi, firewalls, VPN and cloud infrastructure.
• Ensure infrastructure availability, capacity, performance, scalability and lifecycle management.
• Drive infrastructure upgrades, technology refresh and obsolescence management.
• Develop and maintain IT infrastructure policies, SOPs, standards and technical documentation.
• Ensure appropriate testing and qualification of infrastructure following installation or major changes.

Cybersecurity & Information Security

• Own and strengthen the organization's cybersecurity and infrastructure security posture.
• Implement and monitor security controls aligned with ISO 27001, NIST CSF and CIS Controls.
• Manage/oversee security technologies such as firewalls, EDR/XDR, SIEM/SOC, DLP, MFA, PAM and vulnerability management.
• Drive patch management, vulnerability assessments and VAPT activities.
• Establish cybersecurity incident response and recovery processes.
• Monitor cybersecurity risks, incidents and vulnerabilities and report key security metrics to management.
• Drive cybersecurity awareness and phishing-awareness programs.

Pharma / GxP IT Compliance

• Ensure IT infrastructure supporting GxP systems complies with applicable pharmaceutical regulatory requirements.
• Ensure compliance with GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11 and ALCOA+ data integrity principles.
• Support Computer System Validation (CSV) and infrastructure qualification activities.
• Have practical exposure to GAMP 5 Category 1–5 classification, CSV lifecycle, IQ/OQ/PQ and traceability matrices.
• Ensure appropriate controls for user access, privileged access, audit trails, backup, restoration, data retention and electronic records.
• Manage IT-related deviations, change controls, CAPAs, incidents and audit observations.

Regulatory Audits & Inspections

• Act as the key IT representative during FDA, WHO-GMP, MHRA, customer and internal audits.
• Ensure IT policies, SOPs, validation documents and supporting records are audit-ready.
• Drive timely remediation and closure of IT-related audit observations and CAPAs.

IAM, Backup & Disaster Recovery

• Manage enterprise-wide Identity & Access Management (IAM) and Joiner-Mover-Leaver processes.
• Ensure periodic access reviews for critical and GxP systems.
• Manage enterprise authentication, directory services and access controls.
• Establish and maintain backup, Disaster Recovery (DR) and Business Continuity processes.
• Define and monitor RTO/RPO for critical systems and conduct periodic DR drills and backup restoration testing.

Vendor, Budget & Asset Management

• Manage IT infrastructure and cybersecurity vendors, service providers and AMC partners.
• Participate in technical/commercial evaluation and vendor negotiations.
• Maintain IT asset inventory, CMDB, software licenses, warranties and lifecycle plans.
• Manage IT Infrastructure and Information Security CAPEX/OPEX budgets and identify cost optimization opportunities.

Team Leadership

• Lead and develop the IT Infrastructure & Security team.
• Set objectives, review performance, coach team members and build technical/security capabilities.
• Ensure effective knowledge transfer, succession planning and documentation of critical infrastructure.
• Prepare management dashboards covering infrastructure availability, cybersecurity, vulnerabilities, incidents, SLA performance, DR/backup, audit/CAPA status and IT expenditure.

Required Technical Skills

• Data Center, Server & Storage Management
• VMware / Hyper‑V
• SAN / NAS
• LAN/WAN, SD-WAN, MPLS, VPN & Wi‑Fi
• Firewalls and Network Security
• Microsoft Azure / AWS
• Cybersecurity & Information Security
• ISO 27001 / NIST CSF / CIS Controls
• VAPT & Vulnerability Management
• SIEM/SOC, EDR/XDR, DLP, MFA & PAM
• ServiceNow or equivalent ITSM tools
• IT Asset & License Management
• SAP S/4HANA, SAP Business One or equivalent ERP infrastructure support

Pharma Compliance Requirements

Candidates should have hands‑on or strong working experience in:

• GAMP 5
• Computer System Validation (CSV)
• FDA 21 CFR Part 11
• EU GMP Annex 11
• ALCOA+ Data Integrity
• IQ/OQ/PQ and validation documentation
• Change Control, Deviation and CAPA
• Infrastructure Qualification
• Regulatory Audit / Inspection Support
• FDA Computer Software Assurance (CSA) risk‑based approach

Education & Experience

Mandatory:

• B.E./B.Tech in Computer Science / Information Technology / Electronics Engineering
• 15–20 years of relevant IT experience
• Strong experience in IT Infrastructure and Cybersecurity
• Experience in the Pharmaceutical / Life Sciences / GxP environment
• Strong exposure to CSV, GAMP 5, 21 CFR Part 11 and EU GMP Annex 11
• Experience managing IT infrastructure across multiple sites/plants

Preferred:

• M.Tech / MBA in IT or Systems Management
• CISSP / CISM / ITIL / PMP / GAMP 5 certification