Ergomed is hiring a Head of Regulatory Technology Practice

Plan, conduct, and report GxP audits, including technology focused and computerised systems audits, as applicable, across Pharma, Biotech and Healthcare client base. Deliver consultancy services relating to regulated technologies, including governance models, system oversight, risk assessments, compliance gap analyses and inspection readiness activities. Support clients in the implementation and oversight of evolving regulatory expectations relating to AI/ML in GxP settings and risk based QA frameworks. Monitor and interpret emerging global regulatory expectations and industry trends relating to Digital Systems, AI Governance, Data Oversight and technology enabled GxP compliance. Provide strategic and operational leadership in the area of emerging technologies, practices and technology enabled regulatory compliance within GxP environments. Lead the development and growth of the Regulatory Technology Practice across global Pharma, Biotech and Healthcare client base. Collaborate with internal GxP Practices and Subject Matter Experts across CSC, GCP, GVP, GLP, and GMP to establish and integrate digital and technology focused solutions into broader service lines. Drive business development activities through client engagement, proposal development, thought leadership and conference participation. Mentor and support the development of team members within the Regulatory Technology Practice while contributing to the long term strategic direction and scalability of the service line.