Senior Manager, Quality Assurance and Regulatory Compliance

8 hours ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Job Description

We are seeking a highly motivated Senior Manager to join our Quality Assurance team in Copenhagen, Denmark. As a Senior Manager, you will be responsible for leading quality audits within the Good Clinical Practice (GCP) regulated areas, mentoring QA colleagues, developing audit strategies, and coordinating GCP inspection readiness activities.

The ideal candidate will have at least 5 years of experience within GCP and/or Good Laboratory Practice (GCLP), with a strong scientific background in quality assurance and regulatory requirements related to clinical development. You will have excellent analytical skills, attention to detail, and the ability to apply these qualities into a strategic context.

About the Role
  • 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
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
Salary Information

The estimated salary for this role is approximately €90,000 - €110,000 per annum, depending on experience and qualifications. This figure includes a basic salary, plus bonuses and benefits, and is based on the location and industry standards.



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