Head of Regulatory Technology Practice

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Plan, execute, and report on GxP audits, which include technology-specific and computerized systems audits, as necessary, for our Pharma, Biotech, and Healthcare clientele.

• Provide consultancy services regarding regulated technologies, encompassing governance frameworks, system oversight, risk assessments, compliance gap analyses, and activities to ensure inspection readiness.

• Assist clients in adopting and overseeing the evolving regulatory expectations related to AI/ML in GxP contexts and risk-based QA frameworks.

• Monitor and analyze emerging global regulatory expectations and industry trends associated with Digital Systems, AI Governance, Data Oversight, and technology-driven GxP compliance.

• Offer strategic and operational leadership in the domain of emerging technologies, practices, and technology-enabled regulatory compliance within GxP environments.

• Spearhead the development and expansion of the Regulatory Technology Practice across our global Pharma, Biotech, and Healthcare clients.

• Collaborate with internal GxP Practices and Subject Matter Experts across CSC, GCP, GVP, GLP, and GMP to establish and integrate digital and technology-oriented solutions into broader service offerings.

• Propel business development initiatives through client engagement, proposal creation, thought leadership, and participation in conferences.

• Mentor and assist in the development of team members within the Regulatory Technology Practice while contributing to the long-term strategic direction and scalability of the service line.

⛳️ Requirements

• Strong experience in AI/ML/CSV.

• Proven management experience.

• Knowledge of GxP computerized systems validation within regulated environments, with a robust understanding of industry standards and best practices for computer validation, such as GAMP 5, 21 CFR Part 11, Annex 11, and relevant predicate regulations.

• Willingness to travel up to 40% and the capability to conduct remote audits.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• A strong focus on personal and professional growth.

• A friendly and supportive work environment.

• The chance to collaborate with colleagues from around the world, with English as the company’s primary language.