QA GMP Senior Manager

At Genmab, we are dedicated to building extra[not]ordinary® 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 company’s 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 Genmab’s 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,