Senior Manager, QA GMP Pack & Label

Senior Manager, QA GMP Pack & Label

Genmab

Ballerup, Denmark

The Role & Department

Genmab is seeking a Senior Manager for Late-Stage Development QA in Denmark to set quality standards for our development products.

The GMP QA Senior Manager will join the GMP QA Development team, ensuring compliance with industry standards and regulations. This Denmark-based position reports to the Director of GMP QA Development - Drug Product & Clinical Supply. Our Global QA Department has over 50 GXP professionals across Denmark, the Netherlands, the US, Japan, and China.

Candidates should have strong knowledge of GMP guidelines and regulations and be interested in supporting project activities and maintaining compliance.

Key Accountabilities

The main responsibilities of the QA GMP Manager will include, but not be limited to:

• Be QA for our in-house clinical pack and label;
• Perform logbook review, housekeeping, QA oversight of manufacturing activities;
• Perform batch review IMP (Investigational Medicinal Product).

Additionally, the role will have responsibility of the following:

• Oversee and audit vendors and Contract Manufacturing Organisations (CMOs);
• Manage deviations, product complaints, CAPAs, and change controls;
• Support QA for batch manufacturing and product release;
• Ensure documentation and process compliance with relevant standards;
• Contribute to updates of the Pharmaceutical Quality System;
• Maintain effective relationships with internal teams and CMOs;
• Coordinate and deliver GMP training;
• Author SOPs and oversee quality-related documentation;
• Maintain compliance throughout development programmes.

In this Senior Manager role, you will work closely with your GMP QA team, your stakeholders in Technical Operations, Regulatory Affairs and CMOs on IMP. This position offers a valuable opportunity to contribute to development projects within GMP QA. Genmab maintains an innovative portfolio of products designed to advance cancer therapy. There is potential for this role to progress into a Qualified Person delegate (QPd) position.

Skills & Experience

• MSc or equivalent in life sciences;
• 5-10 years’ pharmaceutical QA experience with system qualification;
• Experience in IMP for biologics or sterile products, as well as familiarity with QP‑related responsibilities, is considered highly advantageous;
• EDMS proficiency required;
• GMP lead auditor certification is an advantage;
• Clinical trial development and outsourcing experience desirable;
• Strong English communication and teamwork skills;
• Thrives in a fast-paced, dynamic setting;
• Results-driven and dedicated to Genmab’s success.

About You

• You are genuinely passionate about our purpose;
• You bring precision and excellence to all that you do;
• You believe in our rooted-in-science approach to problem-solving;
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds;
• You take pride in enabling the best work of others on the team;
• You can grapple with the unknown and be innovative;
• You have experience working in a fast-growing, dynamic company (or a strong desire to);
• You work hard and are not afraid to have a little fun while you do so!