Associate Director, QA GCP/PV

1 week geleden

Utrecht, Utrecht, Nederland Genmab Voltijd
About the Role

We are seeking a highly motivated and experienced QA PV Associate Director to join our team at Genmab. As a key member of our Quality Assurance team, you will be responsible for planning, conducting, and reporting on quality audits within the Pharmacovigilance regulated areas.

Key Responsibilities
  • Develop and improve the PV audit strategy and drive the PV audit plan in collaboration with senior QA PV colleagues.
  • Mentor on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across QA GCP & PV.
  • Lead PV inspections readiness activities as well as PV partner audits.
  • Coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.
  • Participate in inspections and audits performed by partners.
  • Represent QA in the PV and Medical Affairs Process Expert Group.
  • Develop and execute internal training of PV requirements and deliver PV advisory expertise within the company and to external vendors.
Requirements
  • MSc in Natural Science or similar and at least 6 years of profound experience within auditing of Pharmacovigilance activities.
  • Experienced Lead Auditor within PV, preferably with knowledge related to outsourced safety processes and internal safety processes.
  • Proficiency in the use and understanding of Veeva Vault QMS is an advantage.
  • Experience with the due diligence process and qualification of new vendors or services.
  • Considered as Domain Expert within PV by peers and has 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.

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