Director Quality and Compliance

Proclinical is working with a specialty pharmaceutical company that is seeking a Director Quality and Compliance to support the company's Global QMS system and support their manufacturing plants to ensure the compliance with EU/US cGMP. The position will be based in Buckinghamshire UK. The incumbent will be supporting/ managing regulatory inspections of manufacturing plants of the company and other plants manufacturing global products.

Job Responsibilities:

• To support all regulatory inspections at company plants or any other plant as assigned time to time, 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 in order to ensure that the company is operating in compliance with Eudralex vol. 4 and 21 CFR part 210/11
• 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

Skills and Requirements:

• A Life Science degree or equivalent preferably in microbiology.
• Experience of dealing with sterile product manufacturing/ quality is essential.
• Have hosted many regulatory inspections by FDA, EMA and other regulatory agencies.
• Preferably understand and communicate in Japanese as well as English languages.
• At broad experience of working within the Pharmaceutical industry of which several years should have been in a QA Management position at a manufacturing site
• Excellent working knowledge of international GMP, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
• Sound knowledge of the principles of Sterile/ biological products manufacturing process.
• Sound knowledge of QC and Stability chemical analytical testing techniques for sterile and biologics.
• Regular Worldwide travel. The position involved travelling 40-50% time.
• As this can be a sedentary position the individual needs to be able to withstand long periods of sitting
• Ability to use VDU equipment
• A degree of flexibility needed with regards to rare occasions where working late/early might be required
• Leading and managing projects
• Interpersonal and communication skills
• Analytical and problem-solving skills
• Team working

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.