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Senior Manager, Research Quality Management

Utrecht, Netherlands

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

Due to our expanding projects and company growth, we are seeking a new colleague to join our team and help us maintain our high quality standards!

The Senior Manager of Research Quality Management is responsible for ensuring research integrity, compliance with regulations, effective risk management, and the maintenance of high-quality standards in research outcomes. In this role, you will support processes within the Research Quality Management team, as well as assist the Head of Research Quality Management. Additionally, your expertise will be crucial in providing essential support to research teams, thereby enhancing efficiency and innovation in our operations.


Are you looking for a diverse and exciting position where you serve as an indispensable link within the company? A role in which you can evolve as a person and grow in your own expertise?

Genmab might have your dream job as Senior Manager, Research Quality Management.

Responsibilities

  • Lead a team of two Senior Associates, Research QM.
  • Business Continuity: Ensure adherence to regulatory standards, conduct and manage audits, and oversee quality control processes to maintain the integrity and continuity of research activities.
  • Coordinate with research teams, maintain documentation accuracy and be responsible for the research training management process.
  • Ensure application of QM work processes by QM personnel and all stakeholders within Research participating in these processes, implement risk management strategies and coordinate data integrity of research projects.
  • Drive quality related process improvements within Research.
  • Define and manage (mid-scale) QM related projects.
  • Being the process expert of QMS related systems (Veeva).


Requirements

  • Bachelor’s degree or equivalent and 6+ years of industry related experience.
  • Experience in a commercial environment with a strong focus on Quality Assurance processes is preferred.
  • Excellent knowledge and understanding of Quality Management System (QMS).
  • Vendor Audit Experience: Extensive experience in conducting vendor audits, including evaluating suppliers' quality systems, processes, and products to ensure compliance with regulatory standards and company requirements.
  • Validated experience in leading projects, including planning, implementing, monitoring, and closing projects successfully.
  • Shown experience with working in teams.
  • Ability to work successfully in a fast-paced environment and with timelines.
  • Ability to be proactive, enthusiastic and results oriented.
  • A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders (e.g. Scientists, Trial Managers, Data Managers, Clinicians, vendors labs) to support product development strategy.
  • Strong communication skills - both oral and written.

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.

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 .

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website https://www.genmab.com/privacy .

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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