Associate Director, QA International and EU Qualified Person job in Amsterdam, Netherlands

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Senior/Director & VP

Location: Netherlands

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting an Associate Director, QA International and EU Qualified Person (QP) for a biotech organisation. This role is on a permanent basis with the ability to work remotely from anywhere in either the Netherlands, Germany, Italy, France or Spain. The client is focused on changing the lives of those suffering from illnesses that have a limited number of insufficient treatment options.

Responsibilities:

Handle third parties such as manufacturing/packaging sites, etc., located in the area which involves qualification, auditing and contracting actions.
Guide and contribute to audits both internally and externally.
Offer QA assistance to the company associates in the area which involves inspection management, upkeep of an insufficient QMS and handle intra-company quality agreements, where required.
When necessary, you will assist with new product launches and projects.
The ideal candidate will certify and release commercial and investigational medicinal products (IMPs) for the European market and clinical studies within Europe.
Evaluate investigational medicinal product reports and any other regulatory/technical papers.
Other duties may be assigned to this role.

Skills & Requirements:

Educated to a degree level in a life science discipline such as pharmacy, biology or chemistry.
Various years of experience as a registered EU qualified person for commercial and/or investigational medicinal products as well as combination products.
Familiarity working within a pharmaceutical organisation in numerous QA or QC and potentially drug substance and drug product manufacturing roles.
Know-how of international regulatory needs connected to commercial products and IMPs.
Acquaintance in a GMP/GDP lead auditor position.
Capable of handling problems, complaints, CAPAs, and alterations through to satisfactory conclusion.
Fluency in the English language with knowledge in additional languages which would be advantageous.
Communication skills both verbally and in writing.
Capable of engaging with staff of all levels which involves clients.
Interpersonal, influential and listening abilities.
Able to prioritise workload.
Works well in a team.
Capable of making decisions with authority.
Comprehension of possible down-stream consequences.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden on +44 203 854 0101.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-JG1

#QACompliance