QA for QC Senior Specialist (GMP QA)
Genmab
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
Genmab´s clinical pipeline is in an exciting growth period, and we are looking for a QA for QC Senior Specialist to join the GMP Quality Assurance (QA) in Denmark.
While existing projects are successfully moving from First-in-Human trials to Late-Stage project development and market authorization approvals, new projects continuously feed into preclinical and early clinical development.
In this position, we are looking for an enthusiastic and experienced candidate to further strengthen the quality area at Genmab. In this new role you be part of a small QA team setting the quality direction for Genmab’s newly established Quality Control laboratory and provide QA for QC expertise within GMP QA.
You have a good knowledge of GMP guidelines and regulations relevant for Genmab’s products, an interest in supporting the daily operations in the QC laboratory, participating in QC related project activities, and safeguard compliance with GMP and other regulatory requirements.
The QC laboratory is part of our CMC area and is located in Ballerup. The laboratory is responsible for supporting Genmab's innovative products by performing release and stability testing.
As QA for QC Senior Specialist, you will be an important part of the global GMP QA team to ensure compliance to industry standards and regulations. The QA GMP team at Genmab currently employs 33 people located in Denmark and US. As our new colleague you will report to Team Lead QA GMP Early Development. The QA Department has a total of 65 employees supporting GxP activities and located in Denmark, the US, China and Japan.
As QA for QC Senior Specialist your workplace will be in Ballerup and additionally sometimes in the Genmab Head Quarters in Valby.
Key Accountabilities
The responsibilities of the QA for QC Senior Specialist will include, but not be limited to:
- QA responsibility for the activities at Genmab’s QC laboratory.
- Promote collaborative relations with relevant internal stakeholders and CMOs.
- Provide QA Support for qualification of analytical instruments as well as analytical method qualification and validation.
- Perform SOP review and writing, handling deviations, CAPAs and change controls.
- Support Genmab’s QC laboratory in building robust, simple and preferably paperless processes
- Handling OOS/OOT in collaboration with the GMP QA teams.
- Enable inspection readiness by ensuring documentation, procedures and processes are maintained in compliance with company and industry standards and global regulations. Provide proficient quality input and drive updates of Genmab’s Pharmaceutical Quality System.
- CMO oversight, e.g. participate in audits of suppliers and contract laboratories
Skills & Experience
- You hold a MSc degree or equivalent in a relevant life science subject.
- You have +5 years’ experience from the pharmaceutical industry preferably within QA for QC.
- Experience with analytical methods for biologics/monoclonal antibodies is an advantage.
- Lead auditor experience is an advantage. You have excellent communication skills in English, and a collaborative mindset.
- As a person you enjoy a fast paced and changing environment.
- You are result and goal orientated and committed to contributing to the overall success of Genmab.
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 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 fixed-term employment contract.