Product Quality Manager

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. Belgium
Brussels Capital Region, Belgium
Posting date: 05 Feb 2024
57884

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.

#QACompliance

close