Job Summary

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.

Responsibilities

- ISMS Implementation (ISO 27001 + DPDP Act + IT Act 2000 Alignment)
1. Lead end-to-end ISMS deployment aligned with ISO 27001 standards
2. Ensure alignment with DPDP Act, IT ACT 2000 and ALCOA+ principles
3. Integrate ISMS controls QA systems

- Annex A Controls Deployment (Hands-on)

1. Possess robust practical knowledge of ISO 27001 Annex A controls
2. Drive actual implementation of controls (not just documentation) across IT and business environments
3. Work closely with businesses, business users, infrastructure, and application teams to:
1. Implement access controls, endpoint security, network security, logging monitoring
2. Ensure backup, DR, patching, vulnerability management, and hardening practices
3. Validate effectiveness of controls through testing and periodic reviews

- Policy, SOP Documentation Framework

1. Develop and maintain:
1. Information Security Policies
2. SOPs and Work Instructions
3. Templates, logs, and records

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

- Audit Readiness Compliance

1.



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

- Data Integrity Security Controls

1. Ensure implementation of controls supporting: i. ISO 27001 ISMS ii. ALCOA+ principles iii. Audit trails, electronic records, and traceability

- Evidence Management Validation Support

1. Collect and maintain ISMS evidences aligned with audits
2. Support validation lifecycle documentation
3. Ensure controls are documented, implemented, and auditable

- Cross-functional Collaboration

1. Liaise with: i. QA/QMS teams for compliance alignment ii. HCD, QC, Production, RD teams for system-level controls iii. IT Infrastructure / Security team for technical implementation
2. Ensure practical deployment of controls, not just theoretical compliance

- Risk Management Governance

1. Conduct risk assessments
2. Maintain risk register and mitigation plans
3. Establish governance dashboards and compliance tracking

- Training Awareness

1. Drive ISMS and cybersecurity awareness programs
2. Educate users on data integrity, phishing, and secure practices
3. Build a culture of compliance and security ownership

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Executive- ISMS (Navi Mumbai)
🏢 yashraj biotechnology
📍 Navi Mumbai