Associate Director, QA GCP/PV

Job

Do you want to safeguard patients and ensure quality compliance in all aspects within Pharmacovigilance? – Then take this great career opportunity!

Are you inspired by working in a company with ambitious goals, exciting development programs, and highly enthusiastic colleagues? Our vision is that by 2030, Genmab’s knock-your-socks-off “KYSO” antibody medicines are transforming the lives of people with cancer and other serious diseases.

We are looking for a highly motivated QA PV Associate Director with at least 6 years of experience in auditing PV activities. You are already an experienced PV lead auditor with the capabilities to train other auditors within Pharmacovigilance.

As QA Associate Director you will have in-depth and strong scientific expertise within quality assurance and all regulatory requirements related to Pharmacovigilance activities. You will have strong analytical skills, high quality standards, detail-oriented with the ability to apply in into a strategic context that enables you to identify solutions within the agreed deadlines.

You will be working in a global team with QA colleagues located in the US, the Netherlands, in Japan as well as in Denmark. Furthermore, you will be part of a strong cross-functional collaboration across the company.

Key responsibilities include:

  • You will plan, conduct, report and follow up on quality audits within the PV regulated areas.
  • You will develop and improve the PV audit strategy and drive the PV audit plan in collaboration with very senior QA PV colleagues.
  • You will develop tools to improve and facilitate the audit processes.
  • Mentoring on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across QA GCP & PV.
  • You will lead PV inspections readiness activities as well as PV partner audits too.
  • coordinate and lead GCP inspection readiness activities for FDA, EMA and PMDA inspections
  • You will participate in inspections and audits performed by partners.
  • You will represent QA in the PV and Medical Affairs Process Expert Group
  • Participate or drive the development, maintaining and improving the Genmab QMS with focus on PV requirements.
  • Develop and execute internal training of PV requirements and deliver PV advisory expertise within the company and to external vendors.

Profile

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-death knowledge related to outsourced safety processes and internal safety processes. It is great if you are also an experienced GCP auditor.
  • Proficiency in the use and understanding of Veeva Vault QMS will be 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.

Moreover, you meet the following personal requirements:

  • Strong analytical skills with eye for the detail and still with the ability to lift it into a tactic and strategic context.
  • Strive in a setting with multiple complex tasks and shifting priorities.
  • Pro-active and open-minded, a dedicated team player with excellent oral and written communication skills

This role is located in Denmark. It is the expectation that the role includes on-site presence combined with the option to work remotely a couple of days per week on average.

Benefits

  • 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

Company profile

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Location Utrecht
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Associate Director, QA GCP/PV

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