Director of QA Compliance, New Position
NonStop is partnered with a global Japanese biopharma that are going through extensive development. Due to success of their product portfolio and an expanding research list they are recruiting over several areas. That also includes this position which will be building a brand new compliance team based from their West London offices.
This role will be working very closely with the Japanese HQ on the global quality compliance strategy and building a structure for the QMS.
* To support all regulatory inspections at plants, including help in preparations, support during inspection, help in preparation of responses to observations etc.
* To ensure that the key elements of the Quality Management System relating to cGMP are effectively implemented.
* To provide advice and support to the site QA team To ensure that there is an appropriate level of QA involvement in the project management meetings in order to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance
Key Experience Needed:
* A degree or equivalent in microbiology.
* Experience of dealing with sterile product manufacturing/QA.
* Hosted regulatory inspections by FDA, EMA and other regulatory agencies.
* A broad experience of working within the Pharmaceutical industry
* Several years in a QA Management position at a manufacturing site
* Excellent working knowledge of international GMP, especially in the interpretation of MHRA and FDA requirements.
* Sound knowledge of the principles of Sterile/biological products manufacturing process.
With this role there is frequent travel to Japan, averaging once per month. Applicants should be prepared for this.
If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Andrew Dixon, at , or by calling me on +44 (0) for a discussion in confidence.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
What I offer: As a specialist Headhunter for the healthcare industry I can offer: market knowledge and a personal service, therefore not just finding you suitable roles but in addition to this offering accurate and honest advice about salaries, work conditions and department reputations for positions across the UK and the EU.
QA, Quality assurance, Director, Senior management, GMP, compliance, Biopharma, biotech, microbiology, UK, Japan, International, London, England, QMS, Inspections, FDA,
- Quality assurance
- Senior management
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