Quality Assurance Director for Pharmacovigilance
1 week ago
At Genmab, we're dedicated to building extraordinary futures together. We develop innovative antibody products and pioneer groundbreaking therapies that transform the lives of patients and change the future of cancer treatment and serious diseases.
Overview
We're seeking a highly motivated Quality Assurance Director for Pharmacovigilance with at least 6 years of experience in auditing PV activities. You'll be responsible for planning, conducting, reporting, and following up on quality audits within the PV regulated areas. Your expertise will drive the PV audit strategy and plan in collaboration with senior QA PV colleagues.
About the Role
- You'll lead PV inspections readiness activities, partner audits, and GCP inspection readiness for FDA, EMA, and PMDA inspections.
- You'll represent QA in the PV and Medical Affairs Process Expert Group.
- You'll participate in inspections and audits performed by partners and deliver PV advisory expertise within the company and to external vendors.
Your Profile
- MSc in Natural Science or similar, with at least 6 years of profound experience within auditing of Pharmacovigilance activities.
- Experienced Lead Auditor within PV, preferably with in-depth knowledge related to outsourced safety processes and internal safety processes.
This role is located in Denmark, offering on-site presence combined with remote work options. As our ideal candidate, you'll bring strong analytical skills, strategic thinking, and excellent communication skills to this dynamic team.
About Our Company
Genmab leverages an agile working environment to promote employee work-life balance. Our collaborative office spaces connect employees while being immersed in state-of-the-art laboratories. Whether in-office or remote, we prioritize connecting with each other to innovate and excel.
Location: Denmark
Estimated salary: €85,000 - €110,000 per year, depending on experience.
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