Product Quality Manager

Proclinical are recruiting for a Product Quality Manager to join a biotech organisation. This role is on a permanent basis and is located in Belgium.

Responsibilities:

• Supervise the performance of the manufacturing and delivery procedures through metrics.
• Assist with the follow up of audits and inspections and guarantee suitable CAPA execution in a timely manner.
• Aid in further build-out of quality procedures and systems.
• Evaluate quality agreements with external parties.
• Help the HA inspection and work with both internal shareholders and external parties to prepare for said inspections.
• Other duties may be assigned to this role.

Key Skills and Requirements:

• Demonstrable experience within a quality assurance role, handling biopharmaceuticals with familiarity within biological manufacturing operations.
• Demonstrable experience with manufacturing and/or lab actions would be beneficial.
• Familiarity working within an outsourced model, in cooperation with a CMO would be advantageous.
• Acquaintance with audits and experience with preparing regulatory inspections such as FDA, EMA, PMDA, etc would be beneficial.
• Expertise on both FDA and EU guidelines and ICH regulations.
• Leadership abilities.
• Works well with others as well as independently.
• Communication skills both verbally and in writing.
• A versatile and flexible individual.
• Technical and analytical abilities.
• Precise in implementation and reporting, quality minded.
• Capable to work within a dynamic environment of a fast-paced setting.
• Fluency in the English language.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.

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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