Senior Computer Software Assurance (CSA) Specialist in Danish Life Sciences Software Scale-Up

(Remote | Asia | Working primarily within EU time zones | International SaaS organization)

At SimplerQMS, we help life-science companies simplify one of the most complex parts of their business: quality and compliance.

We are a Danish-founded SaaS company building a validated eQMS platform used by regulated life-science companies worldwide.

As we continue scaling our platform and release activities, we are strengthening our modern validation and CSA capabilities — and we are looking for a Senior CSA Specialist to help drive that journey.

About the role

This role operates at the intersection between QA, Product, and modern SaaS validation practices.

You will help shape scalable and risk-based validation approaches across the SimplerQMS platform while acting as a strong sparring partner to Product teams regarding software changes, release readiness, validation impact, intended use considerations, and modern risk-based assurance approaches.

We are looking for someone who combines strong validation understanding with pragmatic thinking and who enjoys helping regulated software validation become faster, smarter, and more integrated into modern product development.

Where we are heading

We are evolving our validation approach toward a more continuous, scalable, and automated SaaS model.

This includes strengthening CSA-based validation practices, increasing automated validation evidence, supporting modern release approaches such as feature flags and decoupled deployment and release activities, and embedding validation thinking more directly into day-to-day product development.

We are therefore looking for someone who understands both compliance expectations and modern software delivery realities — including how CI/CD, deployment flows, test automation, and risk-based validation approaches function in practice within a fast-moving SaaS organization.

What you'll be doing

You will help govern CSA-based validation practices across the SimplerQMS platform while supporting scalable, risk-based, and audit-defensible validation approaches across software changes, release activities, infrastructure updates, and validation lifecycle activities.

The role includes maintaining validation scope expectations, validation traceability logic, and validation evidence principles while contributing to scalable validation workflows, modern documentation practices, and continuous improvement of validation efficiency across the organization.

You will collaborate closely with QA, Product, and validation execution teams and participate in customer audits, ISO audits, and validation-related compliance discussions where you will help explain validation rationale and modern risk-based assurance approaches.

What makes you successful in this role

You are analytical, structured, and comfortable navigating complex software quality and validation discussions.

You understand how modern SaaS environments challenge traditional validation approaches and enjoy helping organizations move toward smarter and more scalable validation models without compromising compliance integrity, audit readiness, or operational realism.

You know how to challenge ideas constructively while balancing compliance expectations with practical product realities and release speed, and you likely thrive in environments where software evolves continuously and collaboration across QA and Product teams is essential.

Qualifications

• Strong understanding of computerized systems validation and CSA-based assurance principles
• Familiarity with frameworks such as GAMP5, FDA CSA, ISO 13485, FDA 21 CFR Part 11, or EU GMP Annex 11 is preferred
• Experience with validation lifecycle activities, traceability, software quality, or validation evidence management
• Interest in or experience with CI/CD, feature flags, automated testing, risk-based validation, or validation in frequently released cloud software environments
• Strong analytical, structured, and pragmatic problem-solving capabilities
• Strong written and verbal English communication skills

Education

Bachelor's degree in Software Engineering, Computer Science, Information Technology, Quality Management, Life Sciences, or a related discipline.

Want to learn more

We have prepared a detailed role overview for candidates who would like deeper insight into the responsibilities, collaboration model, expectations, and organizational context behind the role.

SimplerQMS - Senior CSA Specialist - Detailed Role Overview

How to apply

• Click apply and submit your CV.
• All candidates will be invited to complete a short video recording to help us get to know you better. Please note that this step is required to move forward in the process.
• Take the Test Gorilla Assessment here - https://app.testgorilla.com/s/1xsxuprf
• Following the video screening, selected candidates will be invited to at least two rounds of virtual interviews with relevant team members.

All applications are reviewed on an ongoing basis, and you can expect to hear from us within approximately two weeks.

About SimplerQMS

SimplerQMS provides a validated eQMS platform to life-science companies.

We are approximately 25 people connected to our Copenhagen headquarters and around 50 colleagues distributed across 13 additional countries in a remote-first organization.

Across teams and functions, we share a strong preference for thoughtful collaboration, continuous improvement, pragmatic decision-making, and building things properly over time — both in our product and in how we operate as a company.

How we work – The Simpler Way

At SimplerQMS, we believe strong compliance should support scalable and sustainable operations — not create unnecessary bureaucracy.

We care deeply about thoughtful collaboration, low-ego communication, pragmatic problem-solving, and building systems that work well in practice, not only on paper.

Our organization combines a dedicated Product organization responsible for the continuous evolution of the platform with a QA organization focused on validation integrity, operational quality, and regulatory maturity across the company.

Why join SimplerQMS

• Competitive salary and benefits
• Opportunity to grow as the company scales
• A highly international and collaborative work environment
• A high-trust, low-bureaucracy culture
• Flexible remote work setup in Asia
• The opportunity to help shape modern CSA-based validation practices in a regulated SaaS company