Sr. Executive

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)

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

1. Annex A Controls Deployment (Hands-on)

• a. Possess strong practical knowledge of ISO 27001 Annex A controls
• b. Drive actual implementation of controls (not just documentation) across IT and business environments

c. 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

1. Policy, SOP & Documentation Framework

a. Develop and maintain

• i. Information Security Policies
• ii. SOPs and Work Instructions
• iii. Templates, logs, and records
• b. Ensure documentation meets audit expectations
• c. Align with Quality Management System (QMS) documentation

1. Audit Readiness & Compliance

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

1. Data Integrity & Security Controls

a. Ensure implementation of controls supporting

• i. ISO 27001 ISMS
• ii. ALCOA+ principles
• iii. Audit trails, electronic records, and traceability

1. Evidence Management & Validation Support

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

1. Cross-functional Collaboration

a. 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
• b. Ensure practical deployment of controls, not just theoretical compliance

1. Risk Management & Governance

• a. Conduct risk assessments
• b. Maintain risk register and mitigation plans
• c. Establish governance dashboards and compliance tracking

1. Training & Awareness

• a. Drive ISMS and cybersecurity awareness programs
• b. Educate users on data integrity, phishing, and secure practices
• c. Build a culture of compliance and security ownership