Overview
Technical Quality Assurance Associate & CSV Expert – Genedata
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Genedata is seeking a Technical Software QA Associate to lead and manage quality assurance activities from a technical perspective for our Genedata Expressionist Business Unit. This role focuses on defining and ensuring the quality assurance of the developed Expressionist product, rather than software development and testing.
You will oversee the continual improvement of our Quality Management System (QMS), manage software validation efforts, and collaborate with cross-functional teams throughout the software lifecycle. You will also support pre- and post-sales teams by translating user requirements into compliant, validated software solutions that meet customer needs.
If you have a strong background in software QA, regulations like GxP including 21 CFR Part 11 and predicate rules, and enjoy working at the intersection of science, technology, and customer success, we’d love to hear from you.
Key Responsibilities
* Lead and manage all QA activities within the Genedata Expressionist Business Unit, ensuring alignment with regulatory and business objectives
* Continually improve and maintain effective QMS processes to enhance product quality and operational efficiency
* Define, review, and maintain software requirements and documentation in compliance with GxP, FDA 21 CFR Part 11, ISO, and other relevant regulations and standards
* Ensure full traceability from requirements through implementation and testing to support, validation and audit readiness
* Collaborate with cross-functional teams (Product Management, Development, DevOps, Support) to embed quality throughout the software lifecycle
* Provide software validation services to customers in regulated environments, including documentation, test protocols, and audit support
* Act as a subject matter expert on software validation and compliance in both internal and customer-facing contexts
* Support pre- and post-sales teams in understanding user requirements and ensuring successful software solution roll-out in regulated environments
* Train internal teams on compliance topics such as GxP, 21 CFR Part 11, GAMP5, and GDPR
* Facilitate and support internal, customer, and regulatory audits as needed
Your Profile
* Experience: minimum 3 - maximum 10 years in Software QA, ideally in life sciences software industries
* Regulatory Knowledge: Strong understanding of GxP, FDA 21 CFR Part 11, ISO 9001, and GAMP5; experience with audit preparation and compliance documentation
* Compliance-Focused Technical Proficiency: Hands-on experience with software features that support compliance, including electronic records/signatures, audit trails, traceability, and documentation workflows
* Validation Expertise: Proven ability to deliver software validation services to customers, including system lifecycle documentation, test protocols, and audit support
* Education: Bachelor’s or master’s degree in computer science, bioinformatics, or a degree in life sciences with a strong affinity for software/computerized systems validation
* Cross-Functional Collaboration: Skilled in working with product, development, DevOps, and support teams to embed quality throughout the SDLC
* Training & Communication: Capable of training teams on compliance topics and representing QA in customer and regulatory interactions
* Problem-Solving: Strong analytical mindset with the ability to manage risks, resolve issues, and drive continuous improvement
* Continual Professional Development (CPD): Active CPD to strengthen areas of expertise and develop competencies as an impactful Quality Professional
Seniority level
* Associate
Employment type
* Full-time
Job function
* Other
Industries
* IT Services and IT Consulting
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