GMP Quality Partner – Fermentation & Recovery

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

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.