QA GMP Senior Manager

At Genmab we are dedicated to building extranotordinary 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 & 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 companys products we are now looking to further strengthen the QA Commercial & Life Cycle team located in Denmark and the United States.

In this position QA GMP Senior Manager you will set the quality direction for Genmabs Commercial Supply Chain in the EU market. You will be an important part of the global QA GMP 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 - GDP. The QA GMP team at Genmab currently employs 37 people located in Denmark and US.

Responsibilities & Task

• Support vendor oversight activities including audits vendor risk evaluations (VRE) and secure that quality agreement is in place for outsourced GDP activities
• Contribute and support daily operation; meeting with GDP vendors and handling external notification (change control and deviations) and internal Change Control Deviations as well as Product Complaint intake and investigation in compliance with Genmab SOPs and applicable regulatory requirements
• Contribute and support any recall operations for the EU market in collaboration with the global QA GMP team and external partners as necessary
• Contribute shipping lane validation/qualification
• Participate in and contribute to GDP risk assessments related to storage transportation and supply chain operations
• Contribute to the implementation and continuous improvement of Quality systems SOPs and work instructions
• Represent the QA GDP team in global project teams as needed
• Shipment release
• Support of EU Serialization requirements (specific for every country)
• Support that initial and continuous GDP training programs are implemented and maintained.
• Supporting internal audits and regulatory inspections performed by various Health Authorities
• Gaining and maintaining knowledge on new/updated GDP-regulations and guidelines.
• Collaborate with stakeholders in Supply Chain and Commercial Operations to ensure compliant distribution practices
• Handling and improving the Product Complaint intake and investigation in compliance with Genmab SOPs and applicable regulatory requirements

Requirements

• You hold a MSc degree or equivalent in a relevant life science subject
• You have 6 years experience within the pharmaceutical industry within QA GMP/GDP
• Auditor experience is a plus
• You have 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

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 youre 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 Genmabs 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 and follow us on LinkedIn and X.

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