Executive ISMS- Digital Transformation

Role Overview

We are looking for an experienced ISMS Lead to drive end-to-end ISO 27001 implementation in a biotechnology environment, ensuring alignment with GxP, data integrity (ALCOA+), DPDP Act, IT Act 2003 etc. The role will be responsible not only for documentation and audit readiness but also for hands-on deployment of Annex A controls in coordination with the infrastructure, application team & business teams.

1. ISMS Implementation (ISO 27001 + DPDP Act + IT Act 2000 Alignment)

• Lead end-to-end ISMS deployment aligned with ISO 27001 standards
• Ensure alignment with DPDP Act, IT ACT 2000 and ALCOA+ principles
• Integrate ISMS controls QA systems

2. Annex A Controls Deployment (Hands-on)

• Possess strong practical knowledge of ISO 27001 Annex A controls
• Drive actual implementation of controls (not just documentation) across IT and business environments
• Work closely with businesses, business users, infrastructure, and application teams to:

i. Implement access controls, endpoint security, network security, logging & monitoring

ii. Ensure backup, DR, patching, vulnerability management, and hardening practices

iii. Validate effectiveness of controls through testing and periodic reviews

3. Policy, SOP & Documentation Framework

• Develop and maintain:

i. Information Security Policies

ii. SOPs and Work Instructions

iii. Templates, logs, and records

• Ensure documentation meets audit expectations
• Align with Quality Management System (QMS) documentation

4. Audit Readiness & Compliance

• Prepare for and manage ISO 27001 certification audits (Stage 1 & Stage 2)
• Support regulatory audits and inspections
• Ensure timely closure of audit observations and CAPAs

5. Data Integrity & Security Controls

• Ensure implementation of controls supporting:

i. ISO 27001 ISMS

ii. ALCOA+ principles

• Audit trails, electronic records, and traceability

6. Evidence Management & Validation Support

• Collect and maintain ISMS evidences aligned with audits
• Support validation lifecycle documentation
• Ensure controls are documented, implemented, and auditable

7. Cross-functional Collaboration

• Liaise with:

i. QA/QMS teams for compliance alignment

ii. HCD, QC, Production, R&D teams for system-level controls

iii. IT Infrastructure / Security team for technical implementation

8. Risk Management & Governance

i. Conduct risk assessments

ii. Maintain risk register and mitigation plans

iii. Establish governance dashboards and compliance tracking

9. Training & Awareness

i. Drive ISMS and cybersecurity awareness programs

ii. Educate users on data integrity, phishing, and secure practices.

iii. Build a culture of compliance and security ownership