Quality Coordinator: GMP & API Fermentation

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

Job summary

Novo Nordisk A/S in Kalundborg is seeking a Quality Coordinator to join API Fermentation & Recovery. You will maintain the quality system, ensure GMP compliance and collaborate with Production, Support and QA to strengthen quality across the site.

The role blends hands-on quality execution with strategic input, driving deviations, CAPAs, change controls, audits and training, while promoting data integrity and continuous improvement.

Qualifications

• Master's degree in microbiology, chemistry or related field preferred.
• Strong GMP knowledge and experience in regulated production.
• Several years in pharma/biotech/API manufacturing.
• Experience with deviations, investigations, CAPAs, change controls and SOPs.
• Regulatory and quality requirements knowledge.

Responsibilities

• Maintain and improve the department's quality system and GMP compliance.
• Act as trusted quality sparring partner for Production, Support and stakeholders.
• Support and drive deviations, investigations, CAPAs and change controls.
• Drive Quality Activity Plans and quality goals.
• Review SOPs and support implementation of new quality requirements.
• Approve quality documentation on behalf of the department.
• Plan, drive and follow up on audits, inspections and readiness.
• Contribute to Quality Management Reviews (QMR).
• Identify quality trends and opportunities for improvement.
• Initiate corrective actions for quality-system and compliance.
• Plan and facilitate training in cGMP, quality and deviations.
• Promote data integrity practices.
• Represent department within the Quality Coordinator network.
• Make independent quality decisions and challenge stakeholders.

Skills

GMP knowledge

Quality mindset

Stakeholder management

Quality documentation

Regulatory understanding

Communication

Danish language

English communication

Education

Master's degree in microbiology/chemistry

Tools

Quality management systems (QMS)

CAPA software

Job description

Novo Nordisk A/S in Kalundborg is seeking a Quality Coordinator to join API Fermentation & Recovery. You will maintain the quality system, ensure GMP compliance and collaborate with Production, Support and QA to strengthen quality across the site.

The role blends hands-on quality execution with strategic input, driving deviations, CAPAs, change controls, audits and training, while promoting data integrity and continuous improvement.