Senior Manager, QA GCP/PV

2 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're driven to revolutionize the lives of patients through innovative antibody therapies. Our team of passionate professionals is united by a shared purpose: to transform cancer treatment and serious diseases. As a highly motivated QA Senior Manager, you'll be part of our global team that's dedicated to ensuring quality compliance in all aspects within GCP.

We're seeking an experienced lead auditor with at least 5 years of profound experience within GCP and GCLP. You should have in-depth knowledge related to internal process audits and CRO audits of clinical data processing in different IT systems. Additionally, you'll be proficient in Veeva Vault QMS and have experience with due diligence processes and vendor qualification.

As QA Senior Manager, you'll have a deep understanding of regulatory requirements related to clinical development and will be responsible for planning, conducting, reporting, and following up on quality audits within the GCP regulated areas. You'll also mentor on-boarding QA colleagues and experienced lead auditors to increase the competency level across the global QA GCP & PV team.

Key Responsibilities:

  • You'll plan, conduct, report, and follow up on quality audits within the GCP regulated areas.
  • You'll mentor on-boarding QA colleagues as well as experienced lead auditors.
  • You'll develop and maintain audit strategies in collaboration with the Team Lead.
  • You'll coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.
  • You'll participate in inspections and audits performed by our partners.
  • You'll participate in or drive the development, maintenance, and improvement of the Genmab QMS with focus on GCP and GCLP requirements.
  • You'll conduct and coordinate internal GCP training.
  • You'll deliver GCP advisory expertise both within the company and to external vendors.


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