senior mana (Mumbai)

senior mana (Mumbai)

09 Sep
|
Encube Ethicals
|
Mumbai

09 Sep

Encube Ethicals

Mumbai

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 setting
- 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

📌 senior mana (Mumbai)
🏢 Encube Ethicals
📍 Mumbai

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