At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role & Department
The global quality team of Genmab is growing and we are looking for a new team member. Genmab’s QA Quality & Compliance Systems team is part of our Global Quality Assurance function, and we work across GxP areas with compliance, processes and systems. This role supports the compliance support across areas; GLP, GCP, GMP, GDP and IT and monitor the compliance state.
Key responsibilities include
Compliance performance monitoring. You will generate reports and dashboards as part of the compliance monitoring for the organization and Management Functions to maintain an overview of status and progress. Examples of compliance monitoring is Quality management Review reporting and internal and external audit achievements
Participate in or lead projects to improve the way we work in Genmab. Example of an ongoing project led by the team is "Audit improvement" where the existing audit process and system is being revised to better fit the need of our growing company
Support the entire GxP areas in understanding and meeting the internal requirements for Quality Management processes e.g., handling procedures, training, deviation, change control and CAPA handling
Support setting the strategic direction of the quality owned processes
Step in as the deputy for the Senior Director, QA Quality & Compliance Systems when needed
Bachelor’s degree or equivalent and a master’s degree is preferable
7 + years of industry related experience
Excellent knowledge and understanding of the regulatory requirements of minimum one of the GxP areas (GLP, GCP/PV, GMP/GDP, IT)
Strong data analytical skills are a must
AI awareness and possess the skills and mindset to drive change and implement AI driven process
Extensive knowledge and understanding of presenting data and information in excel and/or other suitable tools
Knowledge of Veeva Vault system will be a benefit. Genmab is using Veeva as EDMS
Proven experience working in global teams
Ability to work successfully under pressure in a fast-paced environment and with tight timelines
Ability to be proactive, enthusiastic and goal orientated
Strong English communication skills – both oral and written
This position is Hybrid and can be filled in Copenhagen, Denmark or Princeton, NJ, US.
- 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
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.
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other – rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
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