Own QA across the SDLC for AI-enabled regulated software, manage change control, test case review, audits/CAPAs, customer quality queries, GLP validation, and cross-functional release into GxP environments.
Location:
- UK or Ireland
- Fulltime working from home
- Travel occasionally on-site for team meetings or audits.
Right to Work:
- We are unable to offer UK/Ireland visa sponsorship for this UK/Ireland based role.
About the Role
Patholytix, a subsidiary of Deciphex Ltd., is looking for a Software QA Specialist to join our quality team. This is a rare opportunity to work at the intersection of regulated software quality assurance and cutting-edge AI, you'll be reviewing and shaping the release of AI-powered features into GxP environments used by pharma and life sciences customers around the world.
You'll take ownership of quality across the full software development lifecycle, working closely with our development team and our AI/automation team as new tooling moves from research into regulated production use.
What You'll Do
- Own QA review and approval across the SDLC — change control, test case review and approval, and test management
- Support audits, CAPAs, and documentation control
- Act as a key point of contact for customer quality questions, audit support, and questionnaires
- Review quality assurance clauses in customer SLAs alongside our legal team
- Get involved in the design and development of new features — including AI-based functionality — to ensure they meet quality and regulatory requirements
- Support the release of products into GxP environments for internal and external regulated customers
- Provide QA review and approval across our GXP services offering, including consultant enablement and GLP scanning validation
- Collaborate cross-functionally with our pre-clinical software development team and our AI/automation tooling team
What You'll Bring
- A minimum of 3 years' software development experience within a regulated environment (5 years preferred)
- Genuine, hands-on GXP experience, you understand what "fit for purpose in a regulated environment" really means
- A Bachelor's degree in Computer Science or a related field
- Experience with GLP software validation and verification
- Comfort working in an Agile software development environment
- Strong communication, collaboration, and problem-solving skills
- The ability to work autonomously, you take ownership tasks without needing to be asked
Nice to have:
- Knowledge of GLP regulations, CSV/CSA, FDA 21 CFR 58, 21 CFR 11, OECD Principles of GLP, or GAMP 5 (2nd edition)
- Experience with cloud storage of GLP data
- ISTQB or similar software testing certification
What Will Make You Stand Out
Active, hands-on experience with AI and automation in software development is a major plus. If you've been working on more than "just" standard SaaS QA and have real exposure to how AI features get built, tested, and released — we want to hear from you.
Why Join Patholytix / Deciphex?
- A true sense of meaning in your work, contributing to better patient outcomes
- The chance to work alongside a world-class, high-performing team in a hyper-growth startup environment
- Exciting, challenging, and unique projects — including at the frontier of AI in regulated software
- Regular performance feedback and genuine career growth opportunities
- Competitive salary
- A highly collaborative, supportive, and multicultural team
- Minimal travel — occasional trips for audits or team meetings, with no regular onsite requirement
Deciphex Dublin, Dublin, IRL Office
Dublin, Ireland
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