Quality Coordinator

Novo Nordisk; Kalundborg; On-site; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk in Kalundborg is seeking a Quality Coordinator to maintain and develop the quality system with emphasis on GMP compliance across the Fermentation & Recovery department.

You will balance operational quality support with strategic activities, driving continuous improvement and harmonising quality practices across production areas. Strong communication with Danish and English-speaking stakeholders is essential.

Qualifications

• Master's degree preferred in microbiology, chemistry or related science.
• Strong GMP knowledge and experience in regulated production.
• Several years in pharmaceutical, biotech or API manufacturing.
• Experience with deviations, investigations, CAPAs, change controls, and SOPs.
• Familiar with quality documentation and regulatory requirements.
• Audits/inspections experience.
• Fluency in Danish and good English.
• Able to drive continuous improvement in quality systems.

Responsibilities

• Maintain and continuously improve the department's quality system and GMP compliance.
• Serve as a trusted quality sparring partner for Production, Support and stakeholders.
• Support and drive deviations, investigations, CAPAs and change controls.
• Lead Quality Activity Plans and track quality goals.
• Review SOPs and support new quality requirements and procedures.
• Approve quality documentation and controlled manufacturing documents.
• Plan and follow up on audits and inspection readiness.
• Contribute to Quality Management Reviews.
• Identify quality trends and opportunities for improvement.
• Initiate corrective actions for quality and compliance issues.
• Plan and deliver training in cGMP, quality and deviations.
• Promote data integrity practices within the department.
• Collaborate with internal Quality Coordinators to harmonise activities.
• Make independent quality decisions and challenge stakeholders when needed.

Skills

GMP knowledge

Quality management

Stakeholder management

Communication skills

Danish language

English language

Education

Master's degree in microbiology/chemistry or related field

Job description

Quality Coordinator – API Fermentation & Recovery

Location: Kalundborg, Denmark

Contract: Permanent

Are you passionate about quality and experienced in working within a GMP regulated production evironment? Do you enjoy turning quality requirements into practical solutions, bringing stakeholders together and driving improvements that make a tangible difference to production?

We are looking for a Quality Coordinator to join API Fermentation & Recovery in Kalundborg. This is an opportunity to combine hands on quality expertise with strategic influence, working closely with Production, Support, QA and senior stakeholders to strengthen compliance, drive continuous improvement and further develop robust and effective quality processes.

The position

As Quality Coordinator, you will play a key role in maintaining and developing the quality system and ensuring the right level of GMP compliance across our Fermentation & Recovery department.

This is much more than a coordination role. You will both drive and execute quality activities, applying your own GMP knowledge and judgement while acting as a trusted quality sparring partner to colleagues throughout the organisation.

Your responsibilities will be approximately balanced between operational quality support and more strategic quality activities. You will work closely with Production and Support on day-to-day quality matters while also contributing to quality strategy and collaborating with Quality Coordinators across the wider production area to harmonise approaches and share best practices.

A particular focus will be driving continuous improvement across our quality processes. You will identify trends and opportunities for improvement, challenge existing ways of working and help develop robust systems and processes that support consistently high levels of quality and compliance.

Your Main Responsibilities Will Include

• Maintaining and continuously improving the department's quality system and overall level of GMP compliance.
• Acting as a trusted quality sparring partner for Production, Support and other stakeholders.
• Supporting and, where appropriate, driving deviations, investigations, CAPAs and change controls.
• Driving and following up on departmental Quality Activity Plans and quality goals.
• Reviewing and commenting on SOPs and supporting the implementation of new quality requirements and procedures.
• Supporting controlled and manufacturing documentation and approving relevant quality documentation on behalf of the department.
• Planning, driving and following up on audits, inspections and inspection readiness activities.
• Contributing to Quality Management Reviews (QMR).
• Identifying quality trends, patterns and opportunities for continuous improvement.
• Initiating corrective actions relating to quality-system and compliance issues.
• Planning and facilitating training within cGMP, quality and deviations.
• Supporting and promoting strong data integrity practices within the department.
• Representing the department within the wider Quality Coordinator network, sharing best practices and helping harmonise quality activities across production areas.
• Making independent quality decisions, constructively challenging stakeholders and escalaing concerns when required.

You will report directly into the department leadership and participate in management discussions, giving you the opportunity to influence both operational decisions and the longer-term quality direction of the area.

Qualifications

• A relevant scientific or technical educational background. A Master's degree within areas such as microbiology, chemistry or a related scientific discipline is preferred, although other relevant educational backgrounds combined with substantial experience will also be considered.
• Strong practical knowledge of GMP and experience working within a regulated production environment.
• Several years of relevant experience within pharmaceutical, biotech or API manufacturing.
• Experience working with quality processes such as deviations, investigations, CAPAs, change controls, SOPs and quality documentation.
• An understanding of regulatory and quality requirements within pharmaceutical manufacturing.
• Experience supporting audits, inspections or inspection readiness.
• Strong communication, stakeholder management and facilitation capabilities.
• Fluency in Danish, enabling you to communicate effectively with operators and other Danish speaking stakeholders, together with good English skills.

Experience from API production would be highly advantageous, and knowledge of fermentation and/or recovery processes would be an additional benefit.

More important than having followed one specific career path is your ability to combine a strong quality mindset with an understanding of the realities of production. You are comfortable finding practical solutions within GMP requirements rather than simply identifying the rules.

As a person, you are structured, proactive and able to work independently. You bring the maturity and professional integrity required to contribute to leadership discussions, make decisions and constructively challenge others when necessary. At the same time, you are collaborative and able to bring different stakeholders together around difficult quality decisions.

About The Department

• You will join API Fermentation & Recovery in Kalundborg, an organisation of approximately 170 colleagues within a wider production area of around 600 employees.
• Our department is responsible for an important early stage of the production process and contributes to APIs supporting some of Novo Nordisk's fastest growing products.
• Demand is high, and we are working on capacity initiatives alongside running production to enable us to manufacture even more. Maintaining high quality and compliance while increasing capacity is therefore critical.
• By continuously strengthening our quality systems, processes and ways of working, you will have the opportunity to make a visible contribution to both the performance of our department and support Novo Nordisk's wider production ambitions.

Why Novo Nordisk

Every day, we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward.

For more than 100 years, this dedication has driven us to build a company focused on creating lasting change for long term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results.

Working at Novo Nordisk

Working at Novo Nordisk means joining a global healthcare company with more than 100 years of innovation and a clear purpose: improving the lives of people living with serious chronic diseases.

We offer exciting scientific challenges, opportunities for continuous learning and career development, and the chance to collaborate with talented colleagues across our global manufacturing network.

Salary And Benefits

For this role, the annual base salary ranges from DKK 651,000 to 956,900.00, depending on your experience and competencies.

Incentives and benefits: The package may include short- and/or long-term incentives as well as additional employee benefits, aligned with the position level, location, and market benchmarks.

What We Offer

There is of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.