Director QA/RA

Capillon Analytics

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.

About us

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.

About the role

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.

Key responsibilities

Strategy and leadership

· Define and own the QA/RA strategy, aligned with the business plan and the path to commercial operations

· Take an active part in the management team and in company-wide decisions on priorities, resources and risk

· Build, recruit and lead the QA/RA team in Lund as the company scales

· Own the QA/RA budget and resource planning

· Build a strong quality culture where quality is everyone's responsibility

CAP/CLIA routines and inspection readiness

· Establish and maintain routines that meet the CAP checklists and CLIA requirements

· Build a continuous inspection-readiness process, with self-inspections, gap analyses and corrective-action follow-up

· Ensure competency assessment, training records and delegation of duties meet CAP/CLIA requirements

· Ensure robust processes for all laboratory activities and quality control

· Prepare for and lead external inspections, and respond to any findings

LDT validation and lifecycle

· Develop a framework for LDT validation and verification, covering precision, accuracy, analytical sensitivity and specificity, reference intervals and reportable range

· Ensure traceable change control when methods, instruments, reagents or algorithms change

· Ensure instrument qualification (IQ/OQ/PQ) for current and new equipment

· Support control of software and algorithms in the testing workflow, including testing and validation

Commercial readiness, ISO 15189 and CE-IVDR

· Scale the quality system and laboratory processes for commercial production and higher sample volumes

· Lead the work to align the quality system with ISO 15189, with the goal of being accredited by Swedac

· Own document control, deviations, CAPA, internal audits, risk management and management review

· Lead supplier qualification and oversight of external service providers

· Make sure processes for complaints, post-market follow-up and data integrity are ready for commercial operations

Regulatory strategy

· Own the long-term regulatory pathway in the US and EU, including IVDR, and support entry into new markets

· Act as the company's main contact with authorities, notified bodies and accreditation organisations

Who we think you are

Requirements

· At least 5 years of QA and/or RA experience within pharma or medical devices, IVD or clinical laboratory operations

· Experience leading QA/RA teams, ideally as a head of function or member of a management team

· Experience preparing a company or laboratory for commercial production, scale-up or market launch

· Hands-on experience establishing and maintaining routines under regulated environments, e.g. IDVR or GMP

· Experience with method validation and verification of laboratory tests

· Experience leading inspections and audits, and acting as the main contact with authorities

· A relevant degree, for example in biotechnology, chemistry, life sciences or engineering

· Fluent English, written and spoken

Nice to have

· Experience with CAP/CLIA and LDT operations in the US

· Experience with ISO 15189 accreditation

· Experience with analytical chemistry or mass spectrometry (e.g. ICP-MS or IRMS)

· Experience from a growth company moving from development to commercial operations

· Familiarity with ISO 13485 and IVDR

· Experience implementing and scaling electronic QMS tools and LIMS

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.

What we offer

· A key leadership role in a company with a clear purpose: finding cancer while it can still be cured

· A seat on the management team and a broad mandate to shape quality and regulatory work as we scale

· The opportunity to build and lead your own team in Lund

· A small, dedicated team of scientists and researchers

· An international environment with operations in Sweden and the US

· Flexible working with some remote work possible

Practical information

· Location: Lund, Sweden

· Employment: Full-time, permanent, with an initial probationary period

· Start date: By agreement

· Application deadline: 10 December – we review applications on a rolling basis, so please apply today

· Contact: Henrik Lindblom, COO, henrik@capillonanalytics.com

Apply through our careers page with your CV and a short cover letter.