QA Director - QP/RP

Hobson Prior are looking for a QA Director - QP/RP to support holdings BV for maintenance of MIA and WDA and to also ensure the compliance with EU/US cGMP/GDP requirements. You will join a growing Speciality Pharmaceutical company on a permanent basis in the Netherlands.

Job Responsibilities:

• Accountable to ensure Holding have adequate QMS to support WDA and MIA.
• To be on WDA and MIA licenses.
• Responsible to make sure that the key elements of the Quality Management System relating to cGMP are effectively implemented in order to ensure that the company is operating in compliance with Eudralex vol. 4 and 21 CFR part 210/11.

Requirements:

• A Life Science degree or equivalent.
• You are familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines.
• Previously hosted many regulatory inspections by FDA, EMA and other regulatory agencies.
• Represent as QP under EU regulations.
• Prior involvement of dealing with manufacturing/ quality and distribution requirements of Pharmaceuticals is essential.
• Wide-ranging experience of working within the Pharmaceutical industry of which several years should have been in a QA Management position at a manufacturing site
• Familiar with Quality Management Systems e.g. ICH Q10.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.