Senior Manager QA GCP/PV Lead

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

The Genmab Team Awaits Your Expertise

We are seeking a highly skilled QA Senior Manager to join our team at Genmab, a company dedicated to transforming the lives of patients through innovative cancer treatment. As a key member of our Clinical Development Process Expert Group, you will play a vital role in ensuring the quality and compliance of our clinical trials.

Key Responsibilities:

  • Represent QA GCP in the Clinical Development Process Expert Group and Regulatory Registration PEG, contributing to the development and revision of SOPs.
  • Lead the SOP QA review process, optimizing and aligning QA review and approval of clinical and regulatory SOPs within QA GCP/PV.
  • Ensure transparency and overview of clinical and regulatory SOPs reviewed and approved by QA.
  • Conduct QA review and approval of clinical and regulatory SOPs.
  • Engage QA colleagues in SOP review and approval to ensure timely completion.
  • Lead revisions to GCP/PV QA SOPs, incorporating applicable information and input from QA colleagues.
  • Develop and ensure timely completion of GCP/PV QA relevant SOPs.
  • Coordinate and conduct internal GCP/GCLP training and deviation/CAPA/Change Control processing.
  • Host and manage GCP and PV mailboxes, ensuring efficient organization and access.
  • Provide GCP advisory expertise to the company and external vendors.
  • Explore opportunities for AI and technology advancements in our QA processes.
  • Coordinate and participate in GCP/PV inspection readiness activities.

Requirements:

  • MSc in Natural Science or similar, with at least 5 years of experience in QA GCP and GCLP.
  • Solid project management experience and ability to coordinate QA activities.
  • Experience in clinical CAPAs, deviation, and change control handling within GCP, with training ability.
  • Proficiency in Veeva Vault QMS and understanding of ICH E6(R3) regulation.
  • Strong written and verbal communication skills for SOP writing and GCP training.
  • IT knowledge and experience in data processing are advantageous.

About Genmab and This Role

Genmab leverages an agile working environment to foster employee work-life balance. Our offices are designed as open, community-based spaces that connect employees while being immersed in state-of-the-art laboratories. This role can be located in Copenhagen, Denmark, Utrecht, the Netherlands, or Princeton, New Jersey, U.S., with a hybrid setup requiring 60% on-site presence and two days of remote work per week on average.

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