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Job Details

QUALITY Leader / GMP Qualified Person *** Biologicals *** EU Release and Inspections role *** Rapidly expanding Bio-pharma

Company: Advanced Regulatory (UK & Europe)
Location: The Netherlands
Reference: MGADV / 45000/A
Closing Date: 24 Sep 18
Type: Full Time
Salary (£): Competitive
Benefits: On Application

Job Summary:

To apply for this role, please contact me, Matt Greig, by sending your CV with a covering note to matt@advregulatory.com or alternatively, you can call me, to have a confidential discussion about this or other potential roles, on +447918679405 until 8 pm most evenings and Saturday and Sunday AMs.

Requirements:

QUALITY Leader / GMP Qualified Person *** Biologicals *** EU Release and Inspections role *** Rapidly expanding Bio-pharma with 5 MPs in-line!

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This is a truly unique opportunity to join a major new force in biopharmaceuticals, to be one of their first quality leads as a Qualified Persons for GMP, based in the Netherlands.

I like this role because you will be on the first quality experts on board, so you will help to build a new Quality organization in Europe, and it’s working purely on biologicals. What’s more this organization is achieving impressive expansion, with 150% sales growth on half year sales, just in Europe, similar levels in the US, so your future growth will be assured!

Due to their expansion in Europe, this will feel very much like a start-up, but with 2 major differences, the new offices and European expansion is backed by a strong and large global HQ and global quality organization, and the second, they are already generating >500 million USD in Europe, so this will have notions of being in a start-up, with the backing of a major company with a big footprint!

The role includes Product Quality Management and Release, Inspections Preparation / Co-Hosting, Auditing, so there is a great deal of variety in this role, but what’s more, you will be preparing the BMR for 5 existing biological products, potentially supporting IMPs, for European, some international, and later, US markets.

You will not be alone, the organization has the backing of their global quality group, and part of what you will be doing is to establish the systems and process and future resourcing needs to support their rapid expansion.

Scientifically and technically, you will be an eligible QP for GMP with previous QP experiences, ideally for biologicals, with previous experiences in Inspections preparation, and working with manufacturing for batch release as well as OOS / remediations. Expertise with DS and DP is preferred.

____________________________________________________________________________________

To apply for this role, please contact me, Matt Greig, by sending your CV with a covering note to matt@advregulatory.com or alternatively, you can call me, to have a confidential discussion about this or other potential roles, on +447918679405 until 8 pm most evenings and Saturday and Sunday AMs.

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About Advanced

Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland.

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

Keywords / Key words: Quality Leader, Qualified Person, QP, Industrial Pharmacist, Senior Quality Lead, Quality Director, Quality Head, Quality Management, GMP, IMP, QP, Jobs in QA, Jobs in Quality, Jobs in Quality Product Release, QP roles in biologicals.

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3380
Fax:  +44 (0)20 7228 1188
Website:  Visit Our Web Site

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