Manager, QA GMP

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 located in Denmark and the United States.

As GMP QA Manager you will be a part of the well-functioning QA Commercial & Life Cycle team, with responsibility for quality oversight of starting materials, intermediates, and drug substances for commercial products. You will have a close collaboration with our Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab.

This position will be located in DK, reporting to the Director of QA GMP Commercial & Life Cycle (located in DK). The Global QA Department has 50+ employees supporting GxP activities and located in Denmark, the US and Japan.

Responsibilities & Task

• Maintaining and continuously improving Genmab’s Pharmaceutical Quality System to ensure compliance with EU and US regulations.
• Gaining and maintaining knowledge on new/updated GMP/GDP-regulations and guidelines.
• Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.
• Act as Delegated QP for the release of commercial products (Biological Intermediates, Chemical Intermediates and Drug Substance)
• Reviewing and authoring of QMS SOPs, Work Instructions and other documents, as needed.
• Supporting Quality Management Review and Annual Product Review
• Performing QA activities in relation to US market release in close cooperation with the global QA GMP team, Genmab’s CMOs, contract acceptors and Partners.

• Providing QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities including Audits, Vendor Risk Evaluations, and review and negotiation of Quality Agreements.
• Representing QA GMP in project groups to advise on GMP compliance.
• Participating in internal audits and regulatory inspections performed by various Health Authorities.
• Train QA colleagues and stakeholders in relevant GMP topics
• Promote collaborative relations with relevant internal stakeholders, partners and CMOs.

Requirements

• You hold a Master’s degree or equivalent in a relevant life science subject.
• You have 5+ years experience within the pharmaceutical industry within QA
• Experience with biological and chemical GMP production
• Experience with CMO collaboration
• Experience with audits/inspections
• QP/delegated QP experience

Moreover it is expected that you have the following:

• You have excellent interpersonal skills, problem-solving skills, communication skills in English, and a collaborative attitude.
• 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.
• Pragmatic and yet with attention to the necessary details
• Clear and persistent in your communication, expectations, and requirements to quality

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).

Location: Copenhagen - Carl Jacobsens Vej 30