Director QA/RA

Do you want to lead quality and regulatory affairs in a company on its way from research to commercial reality? Capillon Analytics

is developing a new way to detect cancer early, and we are now entering our next phase: preparing for commercial production and

scaling. As Head of QA/RA, you will join our management team and set the direction for how we get there, with high quality and

full compliance.

Capillon Analytics AB is a biotechnology company with groundbreaking technology based in Medicon Village in Lund. Our

multidisciplinary team consists of leading experts within the field both from academia and life science industry. At Capillon we

are passionate about developing innovative cancer detection solutions that can help save people’s lives. As a startup, we offer a

fast-paced, collaborative, and growth-oriented environment where your contributions will directly influence our success.

IsoTect is offered as a laboratory-developed test (LDT) from our CLIA-registered lab in Lund. We are now looking for an

experienced QA/RA leader to set our quality and regulatory strategy and build the organisation in Lund that takes us into

commercial production and scale.

As Director of QA/RA, you will be part of Capillon's management team and responsible for the company's quality and regulatory

strategy. You will make sure that our quality system, laboratory and organisation are ready for commercial production, higher

volumes and new markets. You will lead the work to keep our CAP/CLIA routines robust and inspection-ready, ensure our LDTs are

validated and monitored in a way that stands up to review, and take us towards ISO 15189 for the EU market. You will report to the

COO and work closely with the CEO and the rest of the team, and you will be our main contact with authorities and accreditation

bodies.

You will build and lead the QA/RA function in Lund, including recruiting and developing your team as the company grows. In the

early phase you will also be hands-on, so you need to enjoy both setting the strategy and doing the work. Since we are paperless

and use digital systems such as LIMS, eQMS and our own digital platform, you will also drive the improvement and scaling of our

digital quality processes.

• Develop a framework for LDT validation and verification, covering precision, accuracy, analytical sensitivity and specificity,

reference intervals and reportable range

As a person, you are a leader who takes ownership and drives the work forward without waiting to be asked. You think strategically

but stay close to the details. You build trust through clear communication and sound judgement, so people follow your lead and the

routines you put in place. You are comfortable making decisions even when the questions are complex and the answers are not black

and white, and you can explain your reasoning to both analysts and the board. You enjoy building teams and developing people.

Capillon Analytics is part of Kreftect Inc. and a member of the Smile incubator. We welcome applicants from all backgrounds and

experiences.