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
With a clear strategy of becoming an integrated end-to-end biotech innovation powerhouse, Genmab recently started to market and sell their own products within cancer treatment. Expanding its focus to also being directly vested in the commercialization of the company’s products, we are now looking to further strengthen the QA Commercial & Life Cycle team in Denmark and the United States. In this position, Quality Assurance (QA) Associate Director, you will set the quality direction for Genmab’s Commercial Supply Chain in the EU market.
As GMP QA Associate Director you will be an important part of the global GMP QA team to ensure compliance with industry standards and regulations. This position will be located in Denmark reporting to the Director of QA GMP, Commercial & Lifecycle. The QA GMP team at Genmab currently employs 32 people in Denmark and US.
Key Responsibilities Include
Contribute to the optimization of global quality management processes to ensure compliance with local regulations and EU regulations.
Support vendor oversight activities including audits, vendor risk evaluations (VRE) and secure that quality agreement is up to date where GMP/GDP activities are outsourced, as required and according to plan.
Support daily operation; meeting with vendors and handling external notification (change control and deviations) and internal Change Control, Deviations etc.
Provide final product dispositions of returned, rejected, quarantined, recalled, or falsified products, in accordance with applicable requirements, agreements, policies, etc.
Contribute and support any recall operations for the EU market in collaboration with the global QA GMP team and external partners, as necessary.
Approve shipping lane validation/qualification.
Handle complaint from the EU market.
Author and continuously improve and update GxP documents in GenDocs, i.e. SOPs, Work Instructions.
Represent the QA GMP team in global project teams as needed.
Provide support with contact and communications with local regulatory agencies & authorities, in collaboration with internal stakeholders as needed, for follow-ups, reporting requirements, and routine GMP/GDP commitments.
Shipment release.
Setup of EU Serialization requirements (specific for every country).
Ensuring that initial and continuous GMP/GDP training programs are implemented and maintained.
Participating in internal audits and regulatory inspections performed by various Health Authorities.
Supporting Quality Management Review and Annual Product Review.
Gaining and maintaining knowledge on new/updated GMP/GDP-regulations and guidelines.
Handling and improving the Product Complaint intake and investigation in compliance with Genmab SOPs and applicable regulatory requirements.
Requirements
You hold a Bachelor/MSc degree or equivalent in a relevant life science subject.
+10 years’ experience within the pharmaceutical industry, preferably within QA GMP/GDP.
Lead auditor experience is a plus.
Excellent interpersonal skills, problem-solving skills, communication skills in English, and a collaborative mindset.
As a person you enjoy a fast-paced and changing environment.
You are results and goal-oriented and committed to contributing to the overall success of Genmab.
You work hard and are not afraid to have a little fun while you do so.
This role is located in Copenhagen, Denmark, and is hybrid.
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 Job Applicant Privacy Notice (genmab.com).
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