(Sr) Product Quality Manager, Commercial Programs
1 dag geleden

To further strengthen our Quality team, we are recruiting an experienced and motivated GMP Product Quality Manager. The GMP Quality Manager will play a pivotal role in further build out of GMP quality infrastructure at argenx in close collaboration with internal business teams.

Reports to :

Head of Product Quality

Key Accountabilities and Responsibilities :

  • In close collaboration with the manufacturing teams oversee external manufacturing of Drug Substance and Drug Product manufacture, depot and supply chain operations for commercial programs :
  • review of deviation investigations and related corrective and preventive actions
  • review of change controls
  • review batch record documentation and support release to market
  • support business review meetings with external parties / CMOs, representing product quality
  • identify, register and monitor compliance risks
  • support CMO projects, validations and Tech Transfers
  • maintains CMO partnership and maintain adequate communication processes
  • Negotiate and reviews quality agreements with external parties .
  • Responsible for generation and monitoring of supplier performance indicators
  • Initiate and or coordinate internal deviation, CAPA and change control records as required
  • Maintains active working relationships and has regular review meetings with internal and external record owners to ensure timey closure
  • Coordinates the generation and review of APQRs in close collaboration with respective CMOs and internal stakeholders
  • Support the Global External Audit Program through the execution of qualification audits and routine GMP audits;
  • Support HA inspection, mock inspections and pre-approval inspections and work with internal stakeholders and external parties to prepare for such inspections.
  • Support follow-up of the above audits and inspections and ensure appropriate and timely CAPA implementation.
  • Support the internal audit program
  • Prepares reports, maintains quality metrics and promotes continuous improvement. Make recommendations to management
  • Support the further build-out of quality processes and systems enabling successful launch and robust supply of commercial product.
  • Authors, revises and or reviews Policies, Standard Orating Procedures and other documents as required

  • Proactively escalates GMP issues to management in case of compliance risk. Assist in the handling and processing of product defect reports to Health Authorities world wide
  • Support other activities within the Product Quality team as required
  • Desired Skills and Experiences :

  • Minimum requirement of a bachelor degree in Sciences
  • 5+ years experience in a commercial quality assurance / compliance related position within the pharmaceutical or life sciences industry.
  • Experience in biological manufacturing operations is an advantage.

  • Previous experience with the management of contracted service providers
  • Track record of identifying and correcting compliance issues
  • Experience with audits and experience with preparation of, and interfacing with regulatory inspections (FDA, EMA, PMDA, ).
  • In-depth knowledge of US and EU cGMP regulations and ICH Guidelines.
  • Strong technical mastery, analytical and investigation skills. Sound decision maker.
  • Able to work effectively together with both internal and external stakeholders.
  • Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines.
  • Fluent in English our working language.
  • Offer :

  • A competitive salary package with extensive benefits
  • Front seat in the development of therapeutic antibodies
  • A work environment in a human-sized, dynamic and rapidly growing biotech company
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