Job Description

The Regional CSV Lead is responsible for establishing and maintaining the framework for Computer Systems Validation (CSV) within the region, ensuring compliance with global and local regulatory requirements (e.g., GxP, FDA 21 CFR Part 11, EU Annex 11). The role will lead and support major validation projects; including enterprise‑level systems such as ERP platforms, while embedding CSV principles into the regional quality management system.

Main Responsibilities:

Validation Strategy:

• Support the design, implementation and maintenance of a regional CSV Quality Management System (QMS) aligned with global standards and corporate policies.
• Develop validation policies, procedures, templates, and training materials.
• Plan and manage large‑scale validation projects (e.g., ERP, LIMS, eQMS, and other GxP‑relevant systems).

Validation Documentation and Risk Assessments:

• Develop, review and execute validation protocols, plans, and reports to ensure accuracy, completeness, and compliance with regulatory expectations.
• Conduct risk assessments for validation activities and develop mitigation plans to address potential issues.
• Review change controls for validated systems to assess impact and validation requirements.

Validation Technical Expertise

• Act as the regional subject‑matter expert (SME) for CSV and data integrity topics, monitoring regulatory trends and emerging guidance to update regional CSV practices accordingly.
• Participation in internal and external audit activities as required
• Deliver CSV training and mentoring to system owners, project managers and quality representatives.

Cross Functional Collaboration

• Collaborate closely with IT, quality assurance, operations and other relevant departments to ensure seamless integration of validation processes.

Skills & Abilities:

• A good understanding of GMP and computer systems validation
• Good numeracy, analytical and IT literacy skills
• Ability to work autonomously across multiple sites and cultures in a regional capacity.
• Excellent project management, communication, and stakeholder‑engagement skills.

Education & Experience: (University degree, work experience, industry, etc.)

• Bachelor’s degree (or higher) in Computer Science, Engineering, Life Sciences or a related field, or equivalent experience.
• Experience in Computer Systems Validation within a regulated industry (pharmaceutical, biotech or medical devices).
• Strong knowledge of GxP requirements, 21 CFR Part 11, EU Annex 11, and data integrity principles.
• Proven experience leading validation of enterprise systems (ERP, LIMS etc.).

City

Lopen Head

State

Somerset

Location Country

United Kingdom

About ADM

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