Remote Senior Validation Lead — CSV & GxP for SaaS Platforms

Dotmatics Ltd.; United Kingdom; Hybrid; GBP 85,000 - 110,000; Full time

Job summary

Dotmatics Ltd. is seeking a Validation Lead to oversee validation for the Luma platform and internal systems under GxP.

You will ensure software development, testing and release activities comply with 21 CFR Part 11, EU Annex 11, GAMP 5 and ISO standards, partnering with Product, Engineering and Quality teams. You will mentor staff, drive risk-based validation strategies and coordinate evidence from IQ/OQ/PQ with automated tools like Cypress/Playwright to ensure audit readiness and customer

Qualifications

• Deep knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 and GxP in software systems.
• Familiar with ISO 9001 quality management principles.
• Experience authoring/executing IQ/OQ/PQ protocols and validation reports with automated testing tools.
• Understanding of SDLC and Agile methodologies.
• Experience validating cloud-based SaaS or COTS software.

Responsibilities

• Lead validation lifecycle activities including VMP, URS, FRS, Traceability Matrix, IQ/OQ/PQ protocols and reports.
• Collaborate with Product, Engineering and Quality teams to drive validation best practices.
• Mentor junior validation staff on CSV principles and documentation.
• Provide guidance for 21 CFR Part 11 controls and regulatory alignment.
• Serve as SME for GAMP5, ISO standards and applicable regulations.

Skills

GAMP 5

21 CFR Part 11

EU Annex 11

GxP requirements

ISO 9001

IQ/OQ/PQ

SDLC

Agile

Cypress

Playwright

Education

Bachelor’s degree in Computer Science/Engineering/Life Sciences

Tools

Cypress

Playwright

Job description

Dotmatics Ltd. is seeking a Validation Lead to oversee validation for the Luma platform and internal systems under GxP.

You will ensure software development, testing and release activities comply with 21 CFR Part 11, EU Annex 11, GAMP 5 and ISO standards, partnering with Product, Engineering and Quality teams. You will mentor staff, drive risk-based validation strategies and coordinate evidence from IQ/OQ/PQ with automated tools like Cypress/Playwright to ensure audit readiness and customer