Senior Manager, QA GCP/PV

6 maanden geleden

Utrecht, Nederland Genmab Voltijd

The Role

& Department

Are you inspired to work in a company with ambitious goals, exciting clinical development programs, and highly enthusiastic colleagues? Our vision by is that Genmab’s knock-your-socks-off “KYSO” antibody medicines will transform the lives of people with cancer and other serious diseases. Do you want to safeguard patients and ensure quality compliance in all aspects within GCP? – Then seize this great career opportunity

We are looking for a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP. You are likely already an experienced QA specialist with strong project management capabilities and skilled in ensuring clinical compliance within our QMS and used to or excited by performing GCP training. You thrive by organizing and coordinating QA activities. You are energized by working in a changing environment. You are familiar with computerized systems in clinical trials and have strong insight of the ICH E6(R3) regulation.

As QA Senior Manager you will have in-depth and strong scientific expertise within quality assurance and all regulatory requirements related to clinical development. You will be able to combine your strong project management skills with your analytical skills and these qualities into a strategic context that enables you to identify solutions within agreed deadlines. 

You will be working in a global team with QA colleagues located in the US, the Netherlands, Japan and Denmark. Furthermore, you will be part of a strong cross-functional collaboration throughout the company.

Key responsibilities include:

  • You will represent QA GCP in the Clinical Development Process Expert Group (PEG) and in the Regulatory Registration PEG where development and revisions of SOPs are being coordinated and planned.

  • You will take the lead on the SOP QA review process where you will optimize and align the process of QA review and approval of the clinical and regulatory SOPs within QA GCP/PV.

  • You will ensure transparency and overview of all the clinical and regulatory SOPs that will be reviewed and approved by QA.

  • You will conduct QA review and approval of clinical and regulatory SOPs.

  • You will engage your QA colleagues in the QA review and approval of SOPs to ensure that timelines are met.

  • You will take the lead when GCP/PV QA SOPs are to be revised to ensure applicable information and input from your QA colleagues are reflected in the applicable QA SOPs.

  • You will be writing GCP/PV QA relevant SOPs and ensuring that timelines are met.

  • You will conduct and coordinate internal GCP/GCLP training or and training in deviation/CAPA/Change Control processing.

  • You will be responsible for the structure and hosting scheme of the GCP and PV mailboxes.

  • You will deliver GCP advisory expertise both within the company and to external vendors.

  • You will be looking for opportunities where AI or similar technologies can advance our way of working.

  • You will coordinate, support, and participate in GCP/PV inspection readiness activities.

Requirements:

  • MSc in Natural Science or similar and at least 5 years of profound experience within QA GCP and GCLP.

  • Solid project management experience and flair for coordinating QA activities.

  • Solid experience in clinical CAPAs. Deviation, change control handling within GCP with the ability to train staff members.

  • Practical proficiency in the use and understanding of Veeva Vault QMS

  • Strong written as well as verbal communication skills that enable you to write SOPs and to perform GCP training as applicable.

  • Knowledge and interest in IT requirement for data processing is an advantage.

Moreover, you meet the following personal requirements:

  • Eye for detail combined with the ability to extract and apply it into a tactical and strategic context.

  • To strive and thrive in a setting with multiple complex tasks and shifting priorities.

  • Pro-active and open-minded, a dedicated team player with excellent oral and written communication skills

This role can be located in Copenhagen, Denmark, or Utrecht, the Netherlands, or Princeton, New Jersey, U.S.

The role is hybrid, with an expectation of 60% on-site presence, combined with the option to work remotely two days per week on average.

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. You are a fierce believer 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 and take 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. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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