Director of Development Quality - Oxfordshire, United Kingdom - Hyper Recruitment Solutions Ltd

Tom O´Connor

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Tom O´Connor

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Description

I'm currently looking for a Director of Development Quality to join a leading diagnostic therapeutics business to successfully lead and support Product development and commercialisation.

In addition, you will be responsible for the following:


KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Director of Development Quality will be varied, however the key duties and responsibilities are as follows:
Lead the selection and qualification of Contract Manufacturing Organisations (CMO's) & Vendors to ensure the successful manufacture of IMP's.

Work closely with CMO's and vendors to develop and improve quality, employing Quality by design principles and risk based methodologies.

Collaborate with CMC colleagues to oversee and support successful technology transfer in accordance to GMP regulations.
Create, maintain and continuously improve and develop the Quality Management System.

ROLE REQUIREMENTS:
Experienced dealing with Tech Transfer projects or establishing and setting up manufacturing facilities.
Proven industry experience within a Senior Quality leadership role within a GMP environment.

  • A working knowledge and practical experience working closely with CMO's.

Key Words:
Director of Quality, CMC, GMP, CMO, QMS, Quality Management System, Radiopharmaceutical, Radiopharma

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