GMP Documentation & Inspection Readiness Associate

Genmab; København; Hybride; DKK 544 000 - 816 000; Plein temps

Avantages offerts par ce poste

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Résumé du poste

Genmab is seeking a Senior Associate to join Global Clinical Supply Manufacturing in Copenhagen with hybrid work options. You will support inspection readiness and ensure documentation is complete, compliant, and ready for GMP and GCP inspections across late-stage trials.

You will collaborate with the Head of Global Clinical Supply Manufacturing and other stakeholders, contributing to broader initiatives and learning across outsourced packaging and labelling activities for IMP and AxMP.

Qualifications

• Minimum bachelor’s degree or equivalent.
• Experience with documentation, quality or compliance in regulated environments is advantageous.
• GMP and GCP knowledge; inspection readiness experience is a plus.
• Interest in documentation, quality and compliance with a detail-oriented approach.
• Ability to coordinate activities across multiple stakeholders.
• Ability to work under pressure in fast-paced environments and during inspections.
• Team player with strong English communication skills.

Responsabilités

• Support inspection readiness across late-stage clinical trials by organizing documentation.
• Perform completeness and compliance checks of trial-specific documents.
• Participate in back-office activities during GMP and GCP inspections.
• Assist in mock inspections, audits and health authority preparations.
• Support functional initiatives and cross-organizational tasks.
• Coordinate activities with external CMOs and vendors as needed.
• Build GMP and clinical supply knowledge through operational tasks.
• Contribute to maintenance and improvement of procedures and tools.
• Ensure compliance with Genmab’s quality system.

Connaissances

Documentation

Quality

Compliance

GMP

GCP

English communication

Formation

Bachelor's degree

Description du poste

Genmab is seeking a Senior Associate to join Global Clinical Supply Manufacturing in Copenhagen with hybrid work options. You will support inspection readiness and ensure documentation is complete, compliant, and ready for GMP and GCP inspections across late-stage trials.

You will collaborate with the Head of Global Clinical Supply Manufacturing and other stakeholders, contributing to broader initiatives and learning across outsourced packaging and labelling activities for IMP and AxMP.