Senior Manager, QA GCP/PV

2 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 lead auditor with the capabilities to train other auditors within GCP/GCLP. You are familiar with internal process audits and CRO audits of clinical data processing in different IT systems. You have a deep knowledge of the requirements related to computerized systems in clinical trials and you understand the impact.

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 have strong analytical skills, high quality standards, and attention to detail as well as the ability to apply 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 plan, conduct, report and follow up on quality audits within the GCP regulated areas.

  • Mentor on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across the global QA GCP & PV team.

  • You will develop and maintain the audit strategies in collaboration with the Team Lead

  • You will coordinate and lead GCP inspection readiness activities for FDA, EMA and PMDA inspections.

  • You will participate in inspections and audits performed by our partners.

  • Participate in, or drive the development, maintenance, and improvement of the Genmab QMS with focus on GCP and GCLP requirements.

  • Conduct and coordinate internal GCP training.

  • Deliver GCP advisory expertise both within the company and to external vendors.

Requirements:

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

  • Experienced Lead Auditor within GCP and/or GCLP, preferably with in-depth knowledge related to internal process audits and CRO audits of clinical data processing in different IT systems.

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

  • Experience with the due diligence process and qualification of new vendors or services.

  • Considered to be a Domain Expert within GCP and/or GCLP by peers with a strong interest and ability to educate others.

Moreover, you meet the following personal requirements:

  • Strong analytical skills with an eye for detail combined with the ability to extract and apply 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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