Head of Regulatory Technology Practice

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🕒 May 16

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ 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.