Quality Assurance Associate Director

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

Transforming lives through innovative cancer treatments is at the heart of Genmab's mission. As a Quality Assurance Associate Director, you'll play a pivotal role in upholding the highest standards of quality and compliance within Pharmacovigilance.

About the Role

We're seeking a highly motivated and experienced individual to lead our Pharmacovigilance Quality Assurance team. As a Senior QA Lead, you'll be responsible for planning, conducting, and reporting quality audits within PV regulated areas. You'll also develop and improve the PV audit strategy, drive the PV audit plan, and mentor on-boarding QA colleagues.

Key Responsibilities

  • Develop and execute internal training programs for PV requirements and deliver PV advisory expertise within the company and to external vendors.
  • Represent QA in the PV and Medical Affairs Process Expert Group and participate in inspections and audits performed by partners.
  • Participate or drive the development, maintaining, and improving the Genmab QMS with focus on PV requirements.
  • Coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.

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 preferable in-depth knowledge related to outsourced safety processes and internal safety processes.
  • Proficiency in the use and understanding of Veeva Vault QMS will be an advantage.

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.

Join Our Team

Genmab is a dynamic and innovative company that values collaboration and excellence. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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