Manager, QA GMP

Manager, QA GMP

At Genmab, were 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 quality area of Genmab is growing and looking for a new colleague. As Quality Assurance (QA) GMP Manager you will work in a global QA GMP team to ensure compliance to industry standards and regulations. You will be responsible for ensuring that operational QA activities are compliant with Genmabs Pharmaceutical Quality System.

You have a good knowledge of GMP guidelines and regulations, an interest in supporting project activities and compliance with GMP and other regulatory requirements.

The QA GMP team at Genmab currently employs 27people located in Denmark and USA. Our new colleague will report to the Team Lead for QA GMP LateStage Development.The Global QA Department has a total of 51 employees supporting GxP activities and located in Denmark, the US, the Netherlands, and Japan.

Key Accountabilities

The main responsibilities of the QA GMP Manager will include, but not be limited to:

• Batch record review for different manufacturing steps.

• Handling deviations, complaints, CAPAs and change controls.

• Enable inspection readiness by ensuring that documentation, procedures, and processes are maintained in compliance with company and industry standards and global regulations.

• Provide proficient quality input and drive updates of Genmabs Pharmaceutical Quality System.

• Assist in GMP training of stakeholders.

This is an exciting job opportunity with responsibilities supporting development projects within QA andoffers many opportunities for further development. Genmab has an exciting development portfolio of new products on the forefront of and aiming to transform cancer treatment.

Skills & Experience

• You hold a MSc degree or equivalent in a relevant life science subject.

• You have 5+ years' experience from the pharmaceutical industry within QA preferably within biologics and/or sterile products.

• 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 youre in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.

When you work with us, youll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.

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.