This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Software QA Specialist based in Ireland.
This role offers a unique opportunity to operate at the intersection of regulated software quality assurance and advanced AI-driven product development. You will ensure that high-impact software solutions used in life sciences and pharmaceutical environments meet strict GxP compliance standards while supporting the delivery of innovative, AI-powered features. Working within a highly collaborative engineering and AI-focused environment, you will play a key role in safeguarding product quality across the full software development lifecycle. You will be deeply involved in validating new features as they transition from research into production, ensuring they meet both regulatory and customer expectations. The position combines hands-on QA ownership, regulatory rigor, and cross-functional collaboration with engineering, automation, and legal teams. This is a fully remote role with occasional travel for audits and team alignment.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Software QA Specialist based in Ireland.
This role offers a unique opportunity to operate at the intersection of regulated software quality assurance and advanced AI-driven product development. You will ensure that high-impact software solutions used in life sciences and pharmaceutical environments meet strict GxP compliance standards while supporting the delivery of innovative, AI-powered features. Working within a highly collaborative engineering and AI-focused environment, you will play a key role in safeguarding product quality across the full software development lifecycle. You will be deeply involved in validating new features as they transition from research into production, ensuring they meet both regulatory and customer expectations. The position combines hands-on QA ownership, regulatory rigor, and cross-functional collaboration with engineering, automation, and legal teams. This is a fully remote role with occasional travel for audits and team alignment.
Accountabilities:
- Own QA oversight across the full software development lifecycle, including change control, test case review, test management, and release validation.
- Ensure compliance with GxP standards and support internal and external audits, CAPAs, and documentation control processes.
- Act as a key QA point of contact for customers, handling quality inquiries, audit requests, and compliance questionnaires.
- Review quality clauses in SLAs in collaboration with legal and commercial teams to ensure regulatory alignment.
- Support the validation and release of software into regulated GxP environments, ensuring readiness and compliance.
- Contribute to the design and testing of new features, including AI-driven functionality, with a strong focus on quality and regulatory requirements.
- Collaborate closely with development, automation, and AI teams to ensure robust, validated software delivery.
- Minimum 3–5 years of experience in software QA or software development within a regulated GxP environment.
- Strong hands-on understanding of GxP principles and what it means to deliver software in regulated life sciences contexts.
- Bachelor’s degree in Computer Science, Engineering, or a related technical field.
- Experience with GLP software validation and verification processes.
- Solid understanding of Agile development environments and QA integration within fast-moving teams.
- Strong communication and stakeholder management skills, with the ability to work autonomously.
- Ability to take ownership of QA tasks and drive them independently from start to finish.
- Familiarity with regulatory frameworks such as FDA 21 CFR Part 11, GLP, GAMP 5, or OECD principles is a plus.
- Exposure to AI/automation in software development or testing is highly desirable.
- ISTQB certification or similar is a plus.
- Competitive salary package aligned with experience
- Fully remote working model (Ireland-based) with minimal travel requirements
- Opportunity to work at the forefront of AI-driven software in regulated life sciences
- High-impact role contributing directly to improved patient outcomes
- Strong career development opportunities in a fast-growing, innovative environment
- Collaborative, international, and highly supportive team culture
- Exposure to cutting-edge AI features moving from research into production
- Occasional travel for audits and team meetings.