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Senior Manager, Training and Compliance, Bioanalytical Science

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.

Senior Manager, Training and Compliance, Bioanalytical Science

The department

The Bioanalytical Science department is responsible for developing fit-for-purpose bioanalytical strategies and methods to quantify drug in circulation and assess unwanted immunogenicity. We are experts in the design, development, validation, execution and interpretation of bioanalytical methods, with a focus on pharmacokinetics/pharmacodynamics (PK/PD), anti-drug antibodies (ADA), neutralizing antibodies (NAb) and soluble markers. We perform bioanalysis activities for both regulated (GLP, GCP) and non-regulated (mouse studies, exploratory tox & Dose Range Finding) studies. As such, we deliver and translate indispensable high-quality bioanalytical data into conclusive insights that power decisions across all stages of Genmab drug development.

Your role at Genmab

As the Senior Manager, Training and Compliance in the Bioanalytical Science department, you will play a pivotal role in maintaining and refining our GLP/GCP compliance system. Reporting to and working with the Team Lead of the BioA Operations team, you will further build on an effective quality framework to safeguard the integrity and reliability of our scientific processes.

You will be the go-to point person for our team and provide guidance and direction to ensure GLP/GCP adherence across all our activities, collaborating closely with Genmab’s Quality Assurance department. You will be responsible for departmental compliance monitoring, training management and archiving, taking a continuous improvement mindset to optimize processes. You will foster an environment in which quality, innovation and productivity find synergy to empower our team to deliver on the Genmab portfolio.

This newly created position integrates several key GxP-related functions currently covered by multiple people into one role. This dedicated focus will further cement BioA GLP/GCP lab compliance by ensuring maximum synergy between (GxP) training, process and archiving activities.

Responsibilities include but are not limited to:

  • Monitor and assist in the initiation and closure of quality events such as Deviations, CAPAs, and Change Controls;
  • Monitor and assist update and periodic revision of GxP (and non-GxP) procedure documents;
  • Oversee the assignment and management of GxP training in Veeva Learning Management System (LMS) and maintain the Bioanalytical Science Training Matrix, ensuring all team members are adequately trained;
  • Further enhance the BioA GxP training experience, including creating new learning modules and implementing new Veeva LMS functionality;
  • Act as the BioA Archivist, responsible for the timely archival of all bioanalytical science documentation;
  • Keep the BioA Master schedule and department dossier up to date;
  • Assist in user administration documentation of BioA E-systems;
  • Offer support and advice to the team on compliance matters, including how to handle deviations and document processes correctly.

What we ask

  • You have a minimum of an HLO or bachelor’s degree preferably in a relevant field (e.g., "bio" chemistry, biotechnology, pharma, food sciences) and >5 years relevant work experience in quality/compliance in a life sciences industry setting;
  • You have demonstrated experience in managing and maintaining quality systems, with skills in Procedure Writing, coordinating Quality Events (e.g., Deviation, CAPAs, Change Control) and Training Management;
  • You have in-depth understanding of regulatory requirements related to GLP/GCP laboratory analysis and knowledge of relevant guidance documents;
  • You are proficient in and/or have affinity for compliance-related software (e.g., Veeva Vault) and strong skills in documentation and record-keeping;
  • You are able to manage multiple tasks with varying degrees of priority simultaneously, meet deadlines, and bring structure to teams with a pragmatic and flexible approach.
  • You are an effective team player with the ability to collaborate cross-functionally, in particularly with highly skilled scientific personnel and Quality Assurance partners;
  • You are fluent in Dutch and English.

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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