Associate Director, Quality Systems

Good Manufacturing Practice (GMP)
Germany
Wuppertal, Germany

Posting date:
18 Jul 2022
46526

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting an Associate Director, Quality Systems for a CMO. This role is on a permanent basis and is located in Wuppertal. The client is focused on providing end-to-end solutions that facilitate associates to find, evolve and engineer biologics.

Responsibilities:

• Guide the periodic management evaluation and yearly product process review/CPV.
• Be a part of the site start-up which involves forming the company's quality system and affiliated leadership surge across all functional areas.
• Contribute to international QMS projects and guarantee international execution and delivery in line with regulatory and client expectations.
• Qualification of the CMO/CRO.
• To assist all GMP/GDP actions, you will assist all areas of the business by cooperating with manufacturing.
• Forming the QMS function which involves the affiliated framework and structure for management of quality linked documentation.
• Any other assigned duties.

Skills & Requirements:

• Educated to a degree level in a biopharmaceutical science or any other similar field, or equivalent qualification with exhibited experience will be considered for this role.
• Acquaintance with operating in a bio-pharma or similar acquaintance within a pharma/science background, as well as CDMO working experience would be ideal.
• Familiarity with guiding a team across various QA functional areas, preferably in a start-up and in sustaining phase.
• Previous involvement in a highly regulated setting, which involves FDA, EMA, and Chinese FDA (NMPA) guidelines relating to API manufacturing.
• Know-how of EU guidelines globally and legislative needs.
• Acquaintance with GMP auditing.
• Qualified as a Qualified Person as per EU Directive 2001/83/EC would be beneficial but not necessary for the role.

If you are having difficulty in applying or if you have any questions, please contact Ayesha Kippie +41 615 687 995
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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