Qualified Person (QP): Quality Assurance Manager

i-Pharm Consulting are supporting a global pharmaceutical group (with a growing number of biologics assets under development) in their search for a Qualified Person (QP) to join them as Quality Assurance Manager for their European operations based out of the Netherlands.

This role would suit someone with experience of QP batch certification for both IMPs and finished Drug Products.

This is an exciting opportunity to strengthen management experience and join a group who have been growing substantially over recent years.

Key responsibilities include (but not limited to):

• Manage quality assurance and compliance activities for commercial drug products on a global level.
• Responsible Qualified Person for the batch release and certification of Drug products for commercial use in Europe.
• Manage the Drug product team
• Manage the quality assurance and compliance activities for Investigational Medicinal products (IMPs) for clinical trials in Europe.
• Responsible Qualified Person for the certification of IMPs for clinical use in Europe.
• Advise and support on quality aspects of IMPs in non-European clinical trials

Who we're looking for:

• Masters Degree (or equivalent) in Chemistry, Pharmacy or relevant scientific field
• Qualified Person status (from within the EU/UK)
• Extensive pharmaceutical industry experience in Quality functions (eg Manufacturing QA, packaging QA, QC, batch review, batch release) - technical EU GMP Guidelines knowledge
• Experience with clinical operations and quality assurance tasks in clinical trials in Europe (EU GCP guideline knowledge)
• Team Leadership experience