(Senior) Associate, Artwork and Compliance

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

The Role

The Compliance and Artwork Associate will work in the CMC Commercial Supply Chain team. You will support the commercial supply chain in CMC in Coordinating Compliance activities and managing routines for Artwork Management with key stakeholders in QA, RA, and external partners.

Besides the operational day-to-day activities within Artwork management and compliance coordination, the role will support building up a GxP compliant commercial supply chain function in terms of systems, processes, and reporting structures.

The position reports to the Senior Director, Commercial Supply Chain.

Responsibilities

• Manage process for artwork preparation, review, and approvals

• Ensure Artwork is prepared according to current rules, procedures, and schedules. Coordinate these activities with internal stakeholders in QA, RA, and external partners (CMO’s and Artwork Provider)

• Manage creation of Change Request for handling artwork changes. Follow up on open changes in order to ensure timely closure and proper house keeping and compliance to internal procedures

• Support Commercial Supply Chain team in documenting procedures, update existing procedures, and work instructions

• Handling of Deviations, CAPA’s and CR’s including following up on actions and acting as driver when relevant

• Follow-up on timelines for department specific compliance tasks overall

• Support preparation of audits and inspections and follow up on actions previous audits

• Work with Quality Assurance in order to maintain GxP compliance throughout the supply chain network including exceptions handling – Investigate exceptions, determine root causes, implement CAPAs and drive closure

Requirements

• Minimum Bachelor’s degree from a relevant education either technical university or business school

• You have knowledge of GMP guidelines and hands-on experience in applying it to an operational environment

• You have 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

Moreover, you meet the following:

• Ability to be proactive, enthusiastic, and goal orientated

• A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders

• Strong communication skills in English - both oral and written

Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.



At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.

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.

Genmab A/S 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: http://www.genmab.com/privacy/applicants-hr-genmab-a-s/

Scam alert

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