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.
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