Senior Manager, QA GCP/PV

2 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

The Role

We are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab. As a QA Senior Manager, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to clinical development.

Key Responsibilities:

  • 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.
  • Develop and maintain the audit strategies in collaboration with the Team Lead.
  • Coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.
  • 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.

About the Role

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.

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