Senior Artwork Specialist

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 being directly vested in the commercialization of the companys products we are now looking to further strengthen the Commercial Supply Chain team in Denmark.

Genmab is looking for a Senior Artwork Specialist to join the team where you will be supporting the commercial supply chain in Technical Operations in Coordinating Compliance activities and managing routines for Artwork Management with key stakeholders in QA RA Supply Chain and external partners.

Besides the operational day-to-day activities within Artwork management and compliance coordination the role will further strengthen our GxP compliant commercial supply chain function in terms of systems processes and reporting structures.

The Senior Artwork Specialist will become a part of the Commercial Supply Chain department and reports to the Team Lead Commercial Supply Chain

Responsibilities

Artwork Management & Coordination:

• Manage the process for artwork preparation review and approvals
• Oversee artwork activities for the US EU and Rest of World markets
• Ensure artwork is prepared in line with current regulations procedures technical specifications and project schedules
• Coordinate artwork-related activities with internal stakeholders (e.g. QA RA Supply Chain) and external partners (e.g. CMOs artwork providers printers)
• Manage creation and closure of Change Requests for artwork changes ensuring compliance with internal procedures and timelines
• Develop and maintain artwork timelines to align with product launches submissions and supply chain activities

Compliance & Quality Assurance

• Maintain GxP compliance throughout the supply chain network including exception handling - investigating deviations determining root causes implementing CAPAs and drive closure
• Participate in audits and inspections serving as subject matter expert on artwork processes
• Ensure timely and accurate documentation of artwork-related activities including version histories approval records and deviation reports

Stakeholder Management

• Serve as the point of contact for artwork-related queries from affiliates internal teams and external vendors
• Facilitate / participate in cross-functional meetings to align on artwork strategy change implementation and project priorities
• Provide training and guidance to internal stakeholders on artwork systems processes and regulatory requirements

Requirements

• Minimum bachelors degree from a relevant education either technical university or business school
• 5 10 years of experience with artwork within the pharmaceutical industry and have knowledge of GMP guidelines and hands-on experience in applying it to an operational environment
• Demonstrated your ability to manage and coordinate tasks across professions
• It is an advantage if you have experience with Veeva Vault artwork management systems and SAP

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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