Senior Quality Operations & Compliance 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 internationally, we are strengthening the operational maturity, audit readiness, and scalability of our Quality Management System and Information Security Management System.

We are therefore looking for a Senior Quality Operations & Compliance Specialist to help strengthen operational quality governance across the organization and ensure that our QMS and ISMS remain effective, scalable, and audit-ready as we continue to grow.

About the role

This role acts as the operational authority within the Quality Operations stream and operates close to the intersection between QA, Customer Success, Product, Sales, Onboarding, and broader operational activities across the company.

You will play a central role in maintaining and improving the operational effectiveness of the QMS and ISMS while helping ensure that quality processes remain structured, scalable, pragmatic, and audit-defensible in a fast-moving SaaS environment.

The role requires someone who combines strong operational QA experience with calmness, authority, and sound judgment — someone who is comfortable leading difficult compliance discussions, driving operational structure across departments, and maintaining audit readiness without creating unnecessary bureaucracy.

You should feel comfortable navigating situations where priorities, timelines, and stakeholder perspectives may differ, while still helping teams move toward pragmatic and operationally sustainable solutions.

What you'll be doing

You will help govern operational QMS and ISMS activities across the organization, including CAPA processes, non-conformance handling, internal audits, supplier quality activities, training governance, audit readiness activities, and broader operational compliance processes.

The role includes maintaining operational quality processes, supporting regulatory alignment activities, strengthening operational quality maturity, coordinating audit readiness efforts, and helping ensure that operational quality processes remain scalable and effective as the organization continues to evolve.

You will collaborate closely with QA leadership and work cross-functionally with Product, Customer Success, Sales, Onboarding, and operational stakeholders across the company.

The role also includes participation in customer audits, ISO audits, supplier audits, and operational compliance discussions where the ability to remain structured, calm, and professionally confident under pressure is essential.

What makes you successful in this role

You are structured, operationally strong, and highly comfortable operating in regulated quality environments.

You know how to maintain operational discipline while still supporting business scalability and operational efficiency, and you understand how to balance compliance expectations with pragmatic day-to-day realities in a growing SaaS organization.

You are naturally calm and solution-oriented during audits, escalations, and compliance discussions, and you are comfortable acting as a trusted operational QA authority across departments.

You likely thrive in environments where priorities evolve continuously, where collaboration across functions is necessary, and where operational quality processes must remain scalable, sustainable, and audit-ready without becoming unnecessarily rigid or bureaucratic.

Qualifications

• Strong practical understanding of ISO 13485, ISO 27001, GxP principles, CAPA systems, audit processes, supplier controls, and risk-based quality management
• Good understanding of software-based Quality Management Systems and regulated SaaS environments
• Understanding of CSA-based quality and validation governance principles is preferred
• Experience leading internal audits, customer audits, CAPA processes, and supplier quality activities
• Strong root cause analysis and structured problem-solving capabilities
• Ability to collaborate effectively across QA, Product, Customer Success, Sales, and operational teams
• Strong written and verbal English communication skills

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Management, Regulatory Affairs, 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 Quality Operations & Compliance 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/mfv0nafe
• 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.

A more detailed role and responsibility description will be shared with relevant candidates during the process.

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 strengthen operational quality maturity and audit readiness in a regulated SaaS company