With a clear strategy of becoming an integrated end-to-end biotech innovation powerhouse, Genmab is now marketing and selling its own products across various markets within cancer treatment.

Genmab is seeking a (Senior) Vice President, Head of QA to lead all GxP related areas, further develop our QA organization, manage resources, and ensure compliance with quality standards.

In this role, you will lead a global team of around 60 highly experienced QA Professionals and report to the CDO in the US.

The position is hybrid and can be filled either in Denmark or the US.

Main responsibilities include:

• Provide QA leadership to the global Quality Assurance team at Genmab.
• Strengthen and develop the QA organization’s competencies in GxP-legislations and QA-practices.
• Prepare and ensure compliance with the department budget.
• Communicate specific QA results/trends to development management and superiors on an ad hoc basis.
• Be part of the R&D and Tech Ops Leadership team.
• Plan and execute QA-related activities within GxP and Genmab’s Quality Management System.
• Oversee GxP inspections performed by health authorities.
• Maintain, develop, and improve Genmab’s Quality Management System.
• Set the audit strategy and evaluate Vendors within GxP regulated areas.
• Maintain Genmab’s Manufacturing license.
• Host the Quality Management review.

Requirements:

• A minimum of Bachelor’s degree or equivalent in scientific discipline or health-related field.
• Minimum of 15 years of experience in Quality Assurance across all GxP related areas and driving QA strategies
• Strong leadership skills with experience in leading global teams of highly qualified QA professionals.
• Strong organizational, communication, and time management skills needed to run multiple ongoing projects simultaneously.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.