{ “@context”: “http://schema.org”, “@type”: “JobPosting”, “title”: “Head of Regulatory Technology Practice”, “description”: “
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.
Qualifications
- 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.
EEO Statement
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.
Benefits
- 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.
Company: Ergomed Group
Location: Guildford
Job Description:
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.
Qualifications
- 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.
EEO Statement
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.
Benefits
- 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.
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Posted: May 20th, 2026