Jason Johal at CK Science is currently recruiting for an Associate Director for GMP to join a global pharmaceutical company based in London.
The role:
As Associate Director of GMP, you will be expected to provide regional strategic direction and oversight for GMP quality for all IMP developmental compounds, and commercial products for which the group is the marketing application holder.
You will also be expected to ensure alignment with global strategic objectives, and participate in the development and implementation of these from Phase 1 through to Phase 3 and 4, and commercial products.
The role also encompasses manufacture, testing, packaging and shipment to ensure compliance with regulatory requirements.
Day-to-day activities will include the management and overseeing of quality requirements of the IMP and MA supply chains (from API to labelled stock, release, importation and distribution) including all vendors, internal and external, ensuring appropriate management of quality compliance requirements including technical/quality agreements, audits, performance and compliance monitoring, feedback and improvements.
There will be the need to ensure that the regulatory release requirements are properly coordinated and that the QP network has available to it all relevant information for batch release and importation (API to study site or commercial distribution releases). There will also be the need to participate in Global Investigational Quality initiatives and regular activities, including meetings in order to assure that developmental GMP quality operations and compliance activities are aligned and compliant with applicable regulations.
The ideal candidate:
To be considered for this Associate Director role you will have extensive experience in commercial and drug development of pharmaceuticals in relevant functions of quality/production/other support functions along with experience in QA/QC in the pharmaceutical industry and managerial or senior level planning or project management experience in a relevant environment.
In addition, you will have specific experience in one or more of the following; IMPs, commercial product supply, clinical research is essential and experience across API, drug substance, drug product, packaging and labelling of pharmaceutical products, preferably in global and multi-disciplinary drug development/production environment is preferred. An understanding and working knowledge of Quality Management Systems with the ability to interpret requirements, anticipate issues, make informed decisions and respond rapidly to emerging quality situations is also essential. Though not essential QP status or training would be welcomed.
How to apply:
For more information or to apply for this Associate Director please contact Jason Johal at CK Science on 01438 723 500 or email jjohal@ckscience.co.uk. Please quote reference ST23186 in all correspondence.
