Quality Manager
This vacancy has now expired. Please see similar roles below...
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 are 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
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 Joseph Emmott on +44 203 8141 316 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.
#LI-JE1
Related jobs
Highly Competitive Salary
München (81249), Deutschland
Proclinical sucht einen engagierten regionalen Vertriebsleiter für die Osthälfte Deutschlands im Bereich Urologie.
Highly Competitive
Deutschland
Proclinical are currently in search of a dynamic Statistical Project Leader.
Highly Competitive
Tuttlingen, Germany
Proclinical sucht einen Systems Engineer - Instruments für einen Kunden aus der Medizintechnik-Branche.
Highly Competitive
Singapore River, Singapore
Proclinical are recruiting for a Senior eCommerce Manager APAC (6 months maternity cover) to join a pharmaceutical organisation.
Highly Competitive
Tuttlingen (78532), Deutschland
Proclinical auf der Suche nach einem Systems Engineer (m/w/d).
Highly Competitive
Singapore
Proclinical is seeking a dedicated Automation Engineer to provide technical support for smooth manufacturing operations.
Highly Competitive Salary
Lexington, USA
Proclinical is seeking a dedicated Project Manager to lead IT projects within business applications and IT infrastructure. This is a contract position located in Lexington, MA.
Highly Competitive Salary
Indianapolis, USA
Proclinical is seeking a dedicated and innovative Electrical Engineer to join our Engineering Operations Team. This is a permanent position located in Indianapolis, IN.
Highly Competitive Salary
New Haven, USA
Proclinical is actively seeking an Upstream Associate Scientist. This is a contract position located in New Haven, CT.
Highly Competitive Salary
Boston, USA
Proclinical Staffing is seeking a Senior Director, of Antibody Bioconjugate Discovery to join an innovative biotech developing next generation neurogenetic medicines.