Head of Regulatory Technology Practice

Job Description

• Plan, conduct, and report GxP audits, including technology focused and computerized 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.

• Strong AI/ML/CSV experience
• Demonstrated management experience
• Knowledge of validation of GxP computerized systems within regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, and applicable predicate regulations.
• Up to 40% travel and ability to conduct remote audits.

As an organization, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language.