Senior Manager, QA GCP/PV

4 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

We are seeking a highly motivated and experienced Quality Assurance Senior Manager to join our team at Genmab. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our clinical development programs.

Key Responsibilities
  • Represent QA GCP in the Clinical Development Process Expert Group (PEG) and Regulatory Registration PEG, coordinating and planning SOPs.
  • Lead the SOP QA review process, optimizing and aligning the process of QA review and approval of clinical and regulatory SOPs within QA GCP/PV.
  • Ensure transparency and overview of all clinical and regulatory SOPs reviewed and approved by QA.
  • Conduct QA review and approval of clinical and regulatory SOPs.
  • Engage QA colleagues in the QA review and approval of SOPs to ensure timely completion.
  • Lead the revision of GCP/PV QA SOPs, ensuring applicable information and input from QA colleagues are reflected.
  • Write GCP/PV QA relevant SOPs and ensure timely completion.
  • Conduct and coordinate internal GCP/GCLP training and deviation/CAPA/Change Control processing.
  • Host and coordinate the GCP and PV mailboxes.
  • Deliver GCP advisory expertise within the company and to external vendors.
  • Explore opportunities to advance our way of working using AI or similar technologies.
  • Coordinate, support, 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.
  • Solid experience in clinical CAPAs, deviation, and change control handling within GCP, with the ability to train staff members.
  • Practical proficiency in Veeva Vault QMS.
  • Strong written and verbal communication skills to write SOPs and perform GCP training.
  • Knowledge and interest in IT requirements for data processing is an advantage.
About You
  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
  • You bring rigor and excellence to all that you do, believing in our rooted-in-science approach to problem-solving.
  • You are a generous collaborator who can work in teams with diverse backgrounds.
  • You are determined to do and be your best, taking pride in enabling the best work of others on the team.
  • You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.

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