Quality Assurance Senior Leader, GCP/GCLP Expert

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

We are looking for a highly motivated QA Senior Manager to join our global team at Genmab. As a key member of our quality assurance department, you will play a critical role in ensuring compliance with GCP and GCLP regulations. Your expertise will be essential in maintaining the high standards of quality and integrity that Genmab strives for.

Your primary responsibilities will include planning, conducting, and reporting on quality audits within the GCP regulated areas. You will work closely with our team to identify areas of improvement and implement corrective actions to ensure seamless operations. In addition, you will mentor on-boarding QA colleagues and experienced lead auditors to enhance their skills and competencies.

About the Role:

This position offers a unique opportunity to contribute to the success of Genmab's mission to transform the lives of patients through innovative antibody therapies. If you are a motivated professional with a passion for quality assurance and regulatory compliance, we encourage you to apply for this exciting opportunity.

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.
  • Develop and maintain 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.


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