Senior Associate, Global Clinical Drug Supply Manufacturing

Genmab; København; Hybrid; DKK 544,000 - 816,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

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.

Responsibilities

• 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.

Skills

Documentation

Quality

Compliance

GMP

GCP

English communication

Education

Bachelor's degree

Job description

The Role

Genmab is searching for an energized Senior Associate to be part of Global Clinical Supply Manufacturing in Copenhagen within commute distance from our office locations to work according to your hybrid work arrangement.

With an impressive pipeline and many ongoing clinical trials, you will have a central role in supporting inspection readiness across our late-stage clinical development portfolio. Your work will help ensure that documentation is complete, compliant and readily available to support the successful execution of business-critical GMP and GCP inspections.

You will support inspection readiness activities within Global Clinical Supply, collecting, organizing and performing completeness and compliance checks of trial-specific documentation. During inspections, you will participate in back-office activities and help ensure timely retrieval and follow-up of requested information.

The role also offers an opportunity to develop beyond inspection readiness. You will work closely with the Head of Global Clinical Supply Manufacturing and support selected functional initiatives, providing exposure to broader activities across the organization and our CMO and vendor network. In parallel, you will have the opportunity to build your GMP and clinical supply knowledge by learning and supporting selected operational activities related to outsourced packaging and labelling of IMP and AxMP.

The position reports to the Director, Head of Global Clinical Supply Manufacturing based in Copenhagen.

Responsibilities

• Support inspection readiness across late-stage clinical trials by collecting, organizing and maintaining relevant clinical supply documentation.
• Perform completeness and compliance checks of trial-specific documentation against applicable procedures and inspection-readiness expectations.
• Participate in back-office activities during GMP and GCP inspections, including document retrieval, request coordination and tracking of responses and follow-up items.
• Support preparation for mock inspections, audits and health authority inspections, including compilation and review of supporting documentation for completeness and readiness.
• Support the Head of Global Clinical Supply Manufacturing with selected functional initiatives and tasks across the organization.
• Support activities related to our external CMO and vendor network, including coordination, follow-up and preparation of relevant material and documentation.
• Build knowledge of GMP and clinical supply activities within Global Clinical Supply Manufacturing and learn and support selected operational tasks related to outsourced packaging and labelling of IMP and AxMP.
• Participate in maintenance and continuous improvement of procedures, tools and ways of working supporting inspection readiness and clinical supply activities.
• Responsible to be compliant with Genmab´s quality system.

Requirements

• Minimum a bachelor’s degree or equivalent.
• Some experience working with documentation, quality or compliance activities in the pharmaceutical, biotech, clinical research or another regulated environment is an advantage.
• Knowledge and understanding of GMP and GCP; experience with inspection or audit readiness is an advantage.
• Strong interest in documentation, quality and compliance, with a structured and detail-oriented approach to your work.
• Ability to coordinate activities, maintain structure and follow up on actions involving multiple stakeholders.
• Ability to work successfully under pressure in a fast-paced environment and with tight timelines, including during inspections.
• Ability to be proactive, enthusiastic, curious and goal orientated, with a willingness to learn new GMP-related activities.
• A team player with demonstrated ability to work effectively with internal and external stakeholders, including CMOs and vendors.
• Strong communication skills in English - both oral and written.

The Team

You will be part of a highly competent team focused on GMP applicable to packaging and labelling of supplies for clinical trials, with a strong focus on quality, inspection readiness and successful collaboration with our internal stakeholders and CMOs.

Together with Global Clinical Supply Portfolio & Project Delivery and Global Clinical Supply Systems, the teams make up the Global Clinical Supply department.

We have an international and informal working environment with a high pace, strong one-team spirit and close collaboration across functions.

Fully remote applicants will not be considered, so please indicate if you are willing to relocate if you’re not currently living in commute distance.

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:

DKK544.000,00---816.000,00

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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