We are seeking a strategic and experienced Chief Quality Officer (CQO) with deep expertise in pharmaceutical development and quality assurance to take full responsibility for Cellcolabs’ quality functions. The role requires strong business acumen, high regulatory integrity, and the ability to operate in an entrepreneurial environment with rigorous quality standards.

As Chief Quality Officer, you will be a member of the Executive Leadership Team. You will have overall responsibility for the company’s quality strategy and for leading the Quality Assurance (QA) and Quality Control (QC) organizations.

About Cellcolabs

Cellcolabs is a biotech impact start-up on a mission to disrupt healthcare as we know it through advanced cell therapies. Mesenchymal Stem Cells (MSCs) have shown groundbreaking potential to cure and treat a myriad of diseases and ailments. Through efficient, large-scale production of MSCs, Cellcolabs fuels the advancement of MSC cell therapies – to ultimately improve global health.

Cellcolabs is based on 20 years of research from Karolinska Institutet and is approved for GMP production of ATMPs by the Swedish Medical Products Agency. We are founded and backed by some of Sweden’s foremost health and life science entrepreneurs as well as Norrsken. Our HQ is in Stockholm, Sweden, with operations and sales across the world. 

Key responsibilities

• Provide strategic leadership and oversight of the company’s Quality Assurance (QA) and Quality Control (QC) functions, ensuring compliance with applicable regulatory requirements throughout the product life cycle.

• Continuously improve the existing Quality Management System (QMS) in alignment with GMP standards and ATMP-specific regulatory expectations.

• Serve as the executive owner of all quality-related activities, including deviation management, CAPA, change control, risk management, OOS-handling and document governance.

• Ensure organizational readiness for regulatory inspections and lead interactions with authorities such as Swedish Medical Products Agency, EMA, FDA, and other international regulatory bodies.

• Act as a key contributor to the Executive Leadership Team, offering expert guidance on quality strategy and compliance in alignment with business objectives.

• Lead and mentor QA and QC teams, including their respective team leads, fostering a culture of quality, accountability, and continuous improvement.

• Drive cross-functional collaboration to support clinical development and the transition from clinical to commercial manufacturing.

• Act as, or prepare to act as, the company’s Qualified Person (QP) in accordance with EU GMP requirements, including oversight of batch release and ensuring product quality and compliance.

Required Qualifications:

• Extensive expertise in GMP and solid knowledge of applicable EU legislation related to ATMP, including regulatory guidelines issued by the EMA. Experience with FDA regulations or those of other non-EU markets is highly desirable.

• Proven senior leadership experience in both Quality Assurance (QA) and Quality Control (QC), with the ability to communicate effectively across all levels of the organization and throughout the full product life cycle.

• Experience with cell cultivation processes and associated analytical methodologies.

• Demonstrated experience from regulatory inspections, particularly those conducted by the Swedish Medical Products Agency, EMA, and FDA.

• Excellent communication skills, both verbal and written, in Swedish and English.

• Ability to operate effectively in a dynamic and fast-paced environment.

• A Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related discipline.

• Educational background and experience that fulfills the regulatory requirements to be eligible as a Qualified Person (QP) under EU GMP guidelines.

• A minimum of 8 years of experience in quality-related roles within the pharmaceutical industry, including at least 3 years in a leadership position.

Desired Qualifications

• Previous experience working in start-up or scale-up environments within the life sciences or pharmaceutical sectors.

• Experience transitioning from paper-based to digital quality systems.

• Relevant experience in regulatory responsibilities within clinical trials, including a clear understanding of the transition from clinical development to commercial manufacturing.

What we offer

Growth

Be part of an innovative, collaborative work environment, working with some of the brightest minds in the field and learning and developing every day.

Culture

We live and work by our shared company values: Nothing is Impossible, Growth, Passion, We Win as One, Joy, and Integrity.

Impact

Be part of our mission to disrupt healthcare as we know it, through advanced cell therapies and make an impact for real with the vision to create good health for everyone.

Benefits

Take part in a compensation package, extensive insurance package including specialist health care and wellness allowance. 

About the role

This full-time role is based in the office in Stockholm, Sweden, and includes international travelling. 

Recruitment Process

We review applications on a rolling basis, so apply as soon as possible. At Cellcolabs, we are committed to building a diverse and inclusive team and warmly welcome applicants from all backgrounds and communities.