Manager Quality Assurance - GLP / GCLP

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

The Quality Assurance team at Genmab is growing. We are looking for a new colleague in an exciting role as QA Laboratory Specialist to be an important player in the QA-GLP policy. You will build on a suitable quality framework ensuring QA Manager GLP/ GCLP compliance within our research facilities and work closely together with our third parties on QA related topics. As QA Laboratory Specialist you will support internal and external audits.

This role is located at our office in Utrecht, The Netherlands, and includes travelling once in a while.
Responsibilities

• Maintaining a suitable quality framework ensuring GLP/ GCLP compliance.

• Conducting applicable QA activities in accordance with regulatory requirements and authority expectations, e.g. facility audits and study audits.

• Ensuring quality oversight activities of suppliers and vendors as well as computerized systems (in collaboration with IT QA) used for GLP activities.

• Ensuring implementation of global processes and systems in the GLP facility.

• General QA support of GLP/ GCLP personnel, including relevant training activities.

• Plan and manage authority inspections.

• Building and maintaining quality awareness and supporting GLP/Bio-analytical organization on quality aspects on a day-to-day basis.

• Support GLP activities in Non-Clinical Safety Plan, conduct, report and follow-up internal audits, external CRO audits and study audits according to procedures.

• Participate in cooperation with Genmab employees, partners and contractors as appropriate to ensure that Genmab’s non-clinical safety studies and GLP/ GCLP work are conducted in compliance with GLP/ GCLP and other regulatory requirements.

• Internal GLP/ GCLP training.

Requirements

• MSc or BSc within life sciences (Biology, Biotechnology, Pharmacy, etc.).

• 5 plus years of experience in QA Management within GLP (GCP could also be applicable).

• Solid experience within GLP/GCLP, from QA or research laboratory organization.

• Team player, highly capable of engaging with stakeholders, effectively works in global organization.

• Excellent verbal and written communication skills in English.

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can 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 maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our 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 to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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 Job Applicant Privacy Notice (genmab.com).

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 contract.