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Associate Director, PV QA

Join a visionary company on their exciting journey and make your mark on a newly established function

 

Y-mAbs is a fast-paced, growing company in the process of expanding its organization to support the continuous growth on commercial activities as well as the exciting clinical pipeline with activities in both early and late-stage clinical development.

As Associate Director, Quality Assurance in the area of Pharmacovigilance (PV) at Y-mAbs you will be part of a team of highly qualified and motivated colleagues in the QA department. You will be the QA PV partner and be a defining part of the newly established function. Further, you will establish QA processes to contribute to Good Pharmacovigilance Practice (GVP) compliance of the company operations.

With direct report to Senior Director Quality Assurance.

Your main tasks are:

  • Contribute to development of the company Quality Management System and provide guidance in local and global requirements, as applicable to Pharmacovigilance
  • Maintain Quality oversight of Pharmacovigilance System Master File, pharmacovigilance SOPs, Safety Management Plans, Pharmacovigilance Agreements, and other relevant documents
  • Sustain Quality oversight of the company PV operations, including case processing, risk management, health authority reporting, and relevant IT system validation and maintenance
  • Conduct audits of vendors relevant to PV areas as well as internal audits in these areas
  • Lead preparation activities for and facilitate PV regulatory inspections
  • Handle deviations, quality investigations and CAPA relevant to PV
  • Train employees and business partners in GVP

Your qualifications involve 7+ years of relevant experience in pharma/biotech industry within QA and/or PV and thorough knowledge of US, EU and global requirements in the area of PV. Further, you have extensive experience and training as an auditor.

Other qulifications are:

  • Knowledge of part 11 compliance requirements to computerized systems, specifically to PV/Safety data bases
  • Record of successful collaboration with license partners, affiliates, etc.
  • Experience in hosting of regulatory inspections
  • Proficiency in English, written and orally
  • Experience with EDMS (knowledge of Veeva Vault is an advantage)
  • Experience in Clinical Drug Safety is an advantage

You have a MSc/BSc in pharmaceutical sciences, biological sciences or similar.

You are a person with good collaboration skills, both internally an with external partners. You must be able to work independently, with multiple tasks, and under ambitious timelines.

Y-mAbs offers an exciting work environment with opportunities for professional development. The position is newly established with a unique opportunity to make an impact in a global fast-growing oncology focused company that strives for becoming the world leader in developing antibody-based cancer products that address clear unmet needs.

Travelling: Up to 30 days per year.

Domicile: Great office location in Hørsholm at DTU Science Park including canteen scheme and easy parking.

For more details about the job or the company, please contact CEO, Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant, Jeanne Dederding, Unique Human Capital on M: +45 28 74 58 71. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
/ /
cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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