Senior Manager, QA GCP/PV

2 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

Genmab is seeking a highly motivated and experienced Senior Manager to lead our Quality Assurance (QA) team in GCP and PV. As a key member of our global QA team, you will be responsible for planning, conducting, and reporting quality audits within the GCP regulated areas.

Key Responsibilities
  • Develop and maintain audit strategies in collaboration with the Team Lead.
  • Mentor on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across the global QA GCP & PV team.
  • 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 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 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.

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