Remote QA Specialist for Regulated AI & GxP Software

deciphex; Ireland; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Patholytix, a subsidiary of Deciphex Ltd., is seeking a Software QA Specialist to join the quality team. You will own QA across the full SDLC and work with our AI/automation teams to ensure products meet regulatory requirements for GxP environments worldwide.

You will collaborate with development and QA teams, support audits, CAPAs, and customer questions, and help shape AI-powered features for regulated production.

Qualifications

• Minimum 3 years' software development in a regulated environment (5 years preferred).
• GXP experience and understanding of regulated environment and fit-for-purpose requirements.
• Bachelor's degree in Computer Science or related field.
• Experience with GLP software validation and verification.
• Comfort working in an Agile software development environment.

Responsibilities

• Own QA review across the SDLC: change control, test case review, and test management.
• Support audits, CAPAs, and documentation control.
• Serve as point of contact for customer quality questions and audit support.
• Review QA clauses in customer SLAs with our legal team.
• Contribute to design/development of AI features ensuring quality and regulatory compliance.
• Support release of products into GxP environments for regulated customers.
• Provide QA review across GXP services, including consultant enablement and GLP scanning.
• Collaborate with pre-clinical software and AI tooling teams.

Skills

GXP experience

QA in SDLC

Agile

Autonomy

Regulated QA

Education

Bachelor's degree in Computer Science

Tools

GLP validation tools

CSV/CSA tooling

Job description

Patholytix, a subsidiary of Deciphex Ltd., is seeking a Software QA Specialist to join the quality team. You will own QA across the full SDLC and work with our AI/automation teams to ensure products meet regulatory requirements for GxP environments worldwide.

You will collaborate with development and QA teams, support audits, CAPAs, and customer questions, and help shape AI-powered features for regulated production.