Associate Director, QA GCP/PV

6 maanden geleden

Utrecht, Nederland Genmab Voltijd

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off 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.

QA PV Associate Director

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 , 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.

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.


 

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

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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