As part of the Product Quality organization, this function will drive operational quality assurance activities at key vendors for commercial biological drug products and plays a role in further build out of GMP quality infrastructure at argenx in close collaboration with internal business teams.
ROLES AND RESPONSIBILITIES:
In close collaboration with vendors, TechOps teams and other Product Quality managers:
1. Manage or review of deviation investigations and related corrective and preventive actions
2. Manage or review of change controls
3. Review batch record documentation and support release of commercial product
4. Manage or review of product complaints
5. Review and assess Product Quality Review (PQR) reports from vendors
6. Support the compiling of submission dossiers and related queries from Health Authorities
7. Review of qualification and validation reports
8. Review of internal quality documents
9. Monitor and trend vendor performance and maintain key performance indicators for key operational QA activities and services associated with the commercial activities
10. Support the activities related to Product Quality Complaint Management
11. Support the further build-out of quality processes and systems and maintenance and continuous improvements of argenx’s QMS system enabling and maintaining successful commercialization of argenx’s products
12. Identify the need for global or local processes in order to ensure compliance to regulatory requirements. Promote and drive the implementation of any such processes in argenx’s quality organization as appropriate
13. Review quality agreements with external parties
14. Communicate with and manage stakeholders in case of product recall, discontinuation of manufacturing or marketing
15. Support the Global External Audit Program through the execution of qualification audits and routine GMP audits
16. Support HA inspection, pre-approval inspections and work with internal stakeholders and external parties to prepare for these inspections
17. Follow-up of the above audits and inspections and ensure appropriate and timely CAPA implementation
18. Support the internal audit program
19. Execute ad hoc quality tasks as relevant to support the international vendor management team
20. Provide expert advice and support on operational and general QA activities for projects part of the commercial portfolio (Process improvement, Technology Transfers).
Desired skills and experiences:
21. 5+ years of experience in a Quality Assurance role, preferably within biopharmaceuticals, with the majority of that time spent in the GMP/GDP area
22. In-depth knowledge of FDA, PMDA, NMPA, EU regulations and ICH Guidelines
23. Experience in the Product Quality Complaint Management
24. Experience with manufacturing and/or lab activities is a plus
25. Ability to work independently and to make decisions based on experience
26. Leadership and communication skills, with the ability to influence individuals at all levels
27. Versatile and flexible working style, also able to independently manage projects and make sound decisions related to product quality issues
28. Strong technical mastery, analytical and investigation skills
29. Quality Auditing experience is a bonus
30. Accurate in execution and reporting, quality-minded
31. Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines
32. Able to work effectively together with both internal and external stakeholders.