Senior Manager Quality Assurance
ProClinical is working with a global sterile manufacturing facility in New York who are active looking for a Quality Manager to assist with the current QMS. The client is a dynamic, fast moving organisation with a global presence. You will be working at a crucial manufacturing site for a unique and innovative business, that forms a key part of their growth strategy both in the USA and globally. This position offers an excellent opportunity to gain experience in a niche area of sterile manufacturing and contribute to a fast-growing business with a proven market presence.
Your primary focus and responsibility will be hosting and handling customer/regulatory audits so experience working with the FDA is crucial. Responsible for the management of 4 specialists (Training, CAPA/Log books, Change Controls and Supplier Quality/Product Reviews) and 1 Document Controller. Most of this staff are highly experienced and act as individual contributors. However, you must have the knowledge and exposure across these departments to accurately answer compliance questions, coming from CEO level, executive management and all the way down to Mechanics on the shop floor. A vital part of your success in this position will be how effectively you 'map' the business so that you can direct questions on QA policies to the correct department or expert (Engineering, Building Services etc)Your primary focus and responsibility will be hosting and handling customer/regulatory audits so experience working with the FDA is crucial.
Skills and Requirements:
- Trackwise experience is critical - if not you must have knowledge of a similar system
- FDA facing - ability to host and answer questions that arise from FDA Inspections as well as selling the business as necessary and representing the company well
- Understanding of the organisations structure
- Proven Sterile QMS experience
- Experience in fast-paced and dynamic business
- Good with time management
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 Keri Marshall on +44 207 440 0679 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.
€0.00 - €75000.00 per annum
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