QMS Manager - GMP

Proclinical is working with a global innovative pharmaceutical company with operations in more than 50 countries. This company is seeking a QMS Manager - GMP to be based in Neuchatel, Switzerland on a permanent basis.

Job Responsibilities:

• Coordinates and performs batch record disposition for manufactured products for late phase (Phase III and beyond) clinical trials.
• Responsible for quality of marketed authorization readiness assessment and liaise with RA for strategy alignment.
• Responsible for compliance review and approval of the following records: batch records/formulation records, release and stability data, method qualification/validation reports, stability protocols, product specification sheets, M/WCB records, IND/IMPD and development reports, etc.
• Performs independent quality evaluation of investigational reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending.
• Reviews and approves deviations, CAPA's, change controls, Quality Control LIR/OOS, Project VMP.
• Participate in project teams to support GMP compliance for the projects.
• Lead and assist in continuous improvement projects as assigned interacts with Team Leader, peers, internal customers, external clients and other cross functional peers to gain alignment on sound quality decisions.
• Provide cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT), high quality performance.

Skills and Requirements:

• Master's degree or equivalent
• Quality professional with minimum 5 years of hands-on experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
• Knowledge of US, EU, PIC/s cGMP guidelines
• Experience in Phase III and BLA requirements
• Manufacturing USP, DSP and/or Quality Control experience is a plus.
• Experience with Quality Systems to include, Batch Record design/review and supporting investigations.
• Good organization skills and attention to detail, with strong verbal and written communication skills.
• Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a flexible and constructive manner.
• Fluent English is required, French is highly desirable.

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 Owen Bach on +44 203 8261 330 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.