Senior Quality Assurance Director, Pharmacovigilance
3 weeks ago
We are seeking a highly motivated Senior Quality Assurance Director, Pharmacovigilance to join our team at Genmab. In this role, you will be responsible for ensuring the quality and compliance of our pharmacovigilance activities.
Key Responsibilities
* Plan, conduct, report, and follow up on quality audits within the pharmacovigilance regulated areas.
* Develop and improve the pharmacovigilance audit strategy and drive the pharmacovigilance audit plan in collaboration with senior QA pharmacovigilance colleagues.
* Develop tools to improve and facilitate the audit processes.
* Mentor onboarding QA colleagues as well as experienced lead auditors to increase the competency level across QA GCP & PV.
* Lead pharmacovigilance inspections readiness activities as well as pharmacovigilance 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 pharmacovigilance and medical affairs process expert group.
* Participate or drive the development, maintenance, and improvement of 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-depth 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.
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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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly experienced Senior Quality Assurance Director to lead our Pharmacovigilance team. As a key member of our quality assurance department, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in all aspects of PV activities.
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