Senior Pharmacovigilance Quality Assurance Director

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're committed to building extraordinary futures through the development of innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose and safeguarding patients.

Job Summary

We are seeking a highly motivated and experienced QA PV Associate Director to join our global team. As a key member of our QA team, you will be responsible for planning, conducting, reporting, and following up on quality audits within the PV regulated areas. Your expertise will be invaluable in developing and improving the PV audit strategy and driving the PV audit plan in collaboration with senior QA PV colleagues.

Key Responsibilities

  1. Develop and implement a comprehensive quality audit strategy to ensure compliance with regulatory requirements.
  2. Conduct quality audits and inspections to ensure compliance with PV regulations and standards.
  3. Mentor and train QA colleagues on PV audit procedures and best practices.
  4. Lead PV inspections readiness activities and partner audits.
  5. Represent QA in the PV and Medical Affairs Process Expert Group.
  6. Participate in the development and maintenance of Genmab's QMS with a focus on PV requirements.

Requirements

  • MSc in Natural Science or similar and at least 6 years of experience in auditing PV activities.
  • Experienced Lead Auditor within PV with knowledge of outsourced safety processes and internal safety processes.
  • Proficiency in Veeva Vault QMS and experience with due diligence processes.
  • Strong analytical skills, eye for detail, and ability to apply in a strategic context.

About Us

Genmab is a dynamic and innovative company that leverages the effectiveness of an agile working environment to connect employees and foster a culture of excellence. Our purpose is to transform the lives of patients through innovative cancer treatment and serious diseases. If you are passionate about our mission and have a strong desire to make a difference, we encourage you to apply for this exciting opportunity.



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