Information Security & GRC Lead (Life Sciences Domain)

About Axtria Founded in 2010, Axtria is a global leader in cloud software and data analytics for the Life Sciences industry. We empower Life Sciences organizations to transform their commercialization strategies and improve patient outcomes through cutting-edge technologies, including Artificial Intelligence, Machine Learning, and Big Data platforms. Serving customers in over 30 countries, Axtria has earned recognition for innovation and growth, making it an industry partner of choice. Why Join Axtria Drive innovation at the forefront of Life Sciences analytics, enabling improved patient outcomes and commercial success Lead a high-impact team delivering transformative enterprise solutions on cloud and AI platforms Collaborate with industry leaders and cutting-edge technology partners in a dynamic, growth-oriented environment Access a global platform recognized for excellence in innovation and client success Key Responsibilities 1. Information Security & GRC Lead the implementation, maintenance, and continuous improvement of ISO 27001 ISMS across life sciences and regulated environments. Drive ISO 27701 (PIMS) implementation with a focus on handling sensitive health, clinical, and patient data. Conduct risk assessments, gap assessments, and internal audits aligned with GxP requirements, regulatory expectations (FDA, EMA), and global privacy laws (HIPAA, GDPR). Develop and maintain security policies, procedures, and control frameworks aligned to regulated workloads (clinical, pharmacovigilance, R&D, real-world evidence platforms). Oversee control testing and audit evidence collection ensuring inspection readiness (regulatory + client audits). Execute internal audits mapped to GxP, data integrity (ALCOA+), and computerized system validation (CSV) expectations. Coordinate external certification and client audits, including CAPA management, audit responses, and closure tracking. 2. SOC 2 Compliance Lead SOC 2 readiness and compliance programs for platforms handling regulated healthcare and life sciences data. Map controls to Trust Services Criteria with emphasis on: Security & Confidentiality of patient and clinical data Availability for critical analytics and decision-support systems Privacy aligned with HIPAA and global privacy frameworks Manage auditor interactions, ensuring alignment between SOC 2 and GxP expectations where applicable. 3. Life Sciences Compliance & Data Governance Ensure adherence to GxP (GCP, GVP, GMP) requirements where applicable to systems and data processes. Support Computerized System Validation (CSV) and 21 CFR Part 11 compliance for regulated applications. Implement controls for: PHI/PII protection and de-identification/anonymization Data integrity (ALCOA+ principles) Audit trails, access control, and electronic records/e-signatures Ensure compliance with HIPAA, GDPR, and other regional data protection regulations for healthcare data. Collaborate with product and engineering teams to embed compliance by design and privacy by design in solutions. 4. Risk Management & Monitoring Perform vendor and third-party risk assessments with focus on clinical data processors, CROs, and healthcare partners. Respond to client security questionnaires, RFI/RFPs (Tier 1, 2, 3) with focus on regulated industry expectations. Track Corrective and Preventive Actions (CAPA) aligned to audit findings, regulatory observations, and client commitments. Establish continuous monitoring mechanisms for critical systems, data access, and regulatory compliance posture. 5. Stakeholder Management & Awareness Deliver targeted security and compliance awareness programs for teams handling clinical, patient, and regulated data. Partner with: Clinical, Pharmacovigilance, and R&D teams Legal, Privacy, and Regulatory Affairs Engineering and Data Science teams Drive a culture of responsible AI, data ethics, and regulatory compliance. Skills & Competencies Strong expertise in: ISO 27001, ISO 27701, SOC 2 GxP regulations, 21 CFR Part 11, HIPAA, GDPR Deep understanding of: Clinical data lifecycle, real-world data (RWD), and healthcare analytics platforms Data integrity principles (ALCOA+) and validation frameworks (CSV) Hands-on experience in risk assessment, audit management, and compliance programs in regulated environments Strong capability in policy drafting, control design, and audit evidence management Excellent stakeholder communication, especially in client-facing and regulatory audit scenarios Preferred Attributes Experience leading compliance programs in Life Sciences / Healthcare organizations or clients Ability to align InfoSec, Privacy, and Regulatory expectations into a unified control framework Strong focus on AI governance in healthcare (bias detection, explainability, data privacy) Domain Exposure Preferred: Clinical Trials / Drug Development Pharmacovigilance Systems Real World Evidence (RWE) Platforms Commercial Pharma Analytics We will provide– (Employee Value Proposition) Offer an inclusive environment that encourages diverse perspectives and ideas Deliver challenging and unique opportunities to contribute to the success of a transforming organization Vast opportunities for self-development: online Axtria Institute, knowledge sharing opportunities globally, learning opportunities through external certifications Possibility to relocate to any Axtria office for short and long-term projects Benefit package: Health benefits Retirement benefits Paid time off Flexible Benefits Hybrid /FT Office/Remote Subsidized food Subsidized parking Axtria is an equal-opportunity employer that values diversity and inclusiveness in the workplace.