Offer summary
Qualifications:
MSc in Natural Science, 5-10 years QA experience in GCP and GCLP.Key responsabilities:
- Represent QA in PEGs
- Conduct QA review of SOPs
- Coordinate training and activities
- Ensure inspection readiness
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
Are you inspired to work in a company with ambitious goals, exciting clinical development programs, and highly enthusiastic colleagues? Our vision by 2030 is that Genmab’s knock-your-socks-off “KYSO” antibody medicines will transform the lives of people with cancer and other serious diseases. Do you want to safeguard patients and ensure quality compliance in all aspects within GCP? – Then seize this great career opportunity!
We are looking for a highly motivated QA Senior Manager/Associate Director with at least 5-10 years of experience within GCP and/or GCLP. You are likely already an experienced QA specialist with strong project management capabilities and skilled in ensuring clinical compliance within our QMS and used to or excited by performing GCP training. You thrive by organizing and coordinating QA activities. You are energized by working in a changing environment. You are familiar with computerized systems in clinical trials and have strong insight of the ICH E6(R3) regulation.
As QA Senior Manager/Associate Director you will have in-depth and strong scientific expertise within quality assurance and all regulatory requirements related to clinical development. You will be able to combine your strong project management skills with your analytical skills and these qualities into a strategic context that enables you to identify solutions within agreed deadlines.
You will be working in a global team with QA colleagues located in the US, the Netherlands, Japan and Denmark. Furthermore, you will be part of a strong cross-functional collaboration throughout the company.
Key responsibilities include:
Requirements:
Moreover, you meet the following personal requirements:
Select one of the following locations: This role can be located in the US, the Netherlands or Denmark.
The role is hybrid, with an expectation of 60% on-site presence, combined with the option to work remotely two days per week on average.
About You
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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