Quality Assurance Manager

Minerva Imaging; Ølstykke; Hybrid; DKK 900,000 - 1,300,000; Full time

Benefits offered by this job

Home-office option

Health insurance

Lunch scheme

Job summary

Minerva Imaging is seeking a Quality Assurance Manager to lead and continuously improve the CRO Quality Management System across studies and activities. You will work with the Quality Group and teams to apply risk-based thinking and drive practical, compliant processes in a dynamic CRO environment.

The role focuses on audits, deviations, CAPAs, document control, training, supplier quality and study quality oversight, with a strong emphasis on stakeholder collaboration and continuous improvement.

Qualifications

• Strong understanding of Quality Management Systems and regulatory requirements.
• Experience leading audits, deviations, CAPAs, root cause investigations.
• Experience with supplier quality and document control.
• Excellent organizational, project management, and stakeholder communication skills.

Responsibilities

• Own and continuously improve Minerva Imaging's CRO Quality Management System with a risk-based approach.
• Lead audits, inspections, deviations, CAPAs, and supplier quality activities; ensure inspection readiness.
• Educate and coach colleagues to strengthen quality culture and ownership.
• Serve as the primary quality partner for clients, management, and operations.

Skills

Quality Management

Audits

CAPA handling

Risk-based thinking

Stakeholder management

English communication

Problem solving

Education

Degree in life sciences or related field

Tools

Electronic Quality Systems

Job description

Are you passionate about building strong quality systems and helping scientific teams deliver reliable, compliant research? Then Minerva Imaging might be your new place of work!

About the job

Minerva Imaging is seeking an experienced and solution-oriented Quality Assurance Manager to lead and continuously improve the Quality Management System for our Contract Research Organization activities. As a non-GLP CRO, we believe quality should support the business and our clients.

As Quality Assurance Manager, you will serve as an independent quality function and collaborate closely with the Quality Working Group and teams across the organization. You will bring a pragmatic, risk-based approach to quality, challenging existing processes where appropriate and developing solutions that are effective, proportionate, and workable in practice.

About the role

You will own the CRO Quality Management System and ensure that studies and supporting activities are conducted in accordance with company procedures, client requirements, applicable regulations, and recognized quality standards. The role combines strategic development of the quality framework with hands-on management of audits, deviations, CAPAs, document control, training, supplier quality, and study quality oversight.

This position is ideal for someone who is comfortable working independently, enjoys extensive stakeholder management, and can translate quality requirements into clear and effective processes in a dynamic CRO environment. Our quality system is evolving, and we are looking for a pragmatic QA leader who thrives in building quality systems that are both effective and workable. You will be comfortable applying risk-based thinking, focusing effort where it creates the greatest value, and helping the organization strengthen compliance without slowing scientific progress.

The position

As Quality Assurance Manager, you will:

• Own and continuously improve Minerva Imaging's CRO Quality Management System, ensuring practical and risk-based compliance.
• Collaborate with the Quality Group and operational teams to maintain high-quality documentation, effective deviation management, and risk-based decision-making across the organization.
• Lead audits, inspections, deviations, CAPAs, and supplier quality activities while maintaining inspection readiness.
• Educate and coach colleagues across the organization to strengthen quality awareness and ownership.
• Serve as the primary quality partner for clients, management, and operational teams, translating quality requirements into fit-for-purpose solutions that support scientific excellence and business objectives.

What will make you successful

You are a collaborative and pragmatic quality professional who:

• Have a strong understanding of Quality Management Systems and apply quality principles with a pragmatic, risk-based mindset.
• Combine auditing, problem-solving, and root cause investigation skills with a focus on practical solutions.
• Work independently, take ownership, and build strong relationships across scientific, operational, and management teams.
• Can influence stakeholders, navigate competing priorities, and translate quality requirements into clear and workable processes.
• Balance structure and compliance with sound judgement, focusing efforts where they create the greatest value.
• Communicate confidently in English and actively promote a culture of quality, learning, and continuous improvement.

Qualifications

• A degree in life sciences, veterinary medicine, pharmacy, biomedical sciences, biotechnology, quality management, or a related field.
• Experience from a CRO, pharmaceutical, biotechnology, medical device, or research environment.
• Demonstrated experience with quality systems, audits, deviations, CAPAs, root cause investigations, and regulatory compliance.
• Experience implementing or maintaining electronic quality systems is preferred.
• Experience supporting client audits and inspections is highly desirable.
• Formal training in Quality Assurance or Quality Management is preferred.
• Excellent organizational, project management, and stakeholder communication skills.

Minerva offers:

We believe in creating an agile working environment, so we have flexible working options including the option of working from home. We care about our employees' well-being and offer health insurance and a quality conscious lunch scheme and monthly social activities.

We are an informal organization with a strong focus on open and honest communication. We value humour and a natural care for one another.

About Minerva Imaging:

Minerva Imaging is a scientifically driven and fully integrated Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) specializing in targeted radionuclide therapies.

We support translational research and drug development through the use of advanced preclinical animal models within oncology and cardiovascular diseases, combined with state-of-the-art in vivo molecular imaging. By working in close partnership with our sponsors, we seek to understand their scientific challenges and jointly identify how our expertise, technologies, and methods can deliver robust and meaningful answers.

Our modern facility in Ølstykke, Denmark offers best-in-class, fully integrated radiopharmaceutical research, development, and manufacturing capabilities - covering the entire value chain from early research to clinical supply.

Backed by Nordic Capital since 2026, Minerva Imaging is executing an ambitious growth strategy aimed at strengthening our position as a market leader within targeted radionuclide therapies. This growth journey offers exciting opportunities for individuals who want to contribute to cutting-edge science in a dynamic and international environment.

Minerva Imaging is an equal opportunity employer, and we welcome applications from qualified candidates regardless of background or experience. In accordance with our recruitment policy, all candidates are required to provide a personal criminal record as part of the hiring process.

Follow us on LinkedIn for the latest news updates or visit www.minervaimaging.com for more information.