QA Senior Manager: Delivering Excellence in Clinical Trials

6 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

Are you a quality assurance expert looking to take your career to the next level?

We are seeking a highly motivated QA Senior Manager to join our team at Genmab, a leading biotechnology company dedicated to transforming the lives of patients with cancer and other serious diseases.

About the Role

This is a unique opportunity to work in a global team with QA colleagues located in the US, the Netherlands, Japan, and Denmark. As a QA Senior Manager, you will be responsible for planning, conducting, reporting, and following up on quality audits within the GCP regulated areas.

You will also mentor on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across the global QA GCP & PV team. Additionally, you will develop and maintain the audit strategies in collaboration with the Team Lead and coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.

The ideal candidate will have an MSc in Natural Science or similar and at least 5 years of profound experience within GCP and GCLP. They should also be an 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.

Key Responsibilities

Job Description:

  • 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
  • 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
  • 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
  • At least 5 years of profound experience within GCP and GCLP
  • Experienced Lead Auditor within GCP and/or GCLP
  • PRACTICAL PROFICIENCY IN VEEVA VAULT QMS
  • Experience with due diligence process and qualification of new vendors or services
  • Considered to be a Domain Expert within GCP and/or GCLP by peers

Salary Range:

$120,000 - $160,000 per annum, depending on location (Copenhagen, Denmark; Utrecht, the Netherlands; Princeton, New Jersey, U.S.) and experience.

Work Environment:

Genmab offers a hybrid work arrangement with an expectation of 60% on-site presence and the option to work remotely two days per week on average. Our offices are designed as open, community-based spaces that foster collaboration and innovation.

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 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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