Product Quality Manager
Il y a 6 mois
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:
- Manage or review of deviation investigations and related corrective and preventive actions- Manage or review of change controls- Review batch record documentation and support release of commercial product- Manage or review of product complaints- Review and assess Product Quality Review (PQR) reports from vendors- Support the compiling of submission dossiers and related queries from Health Authorities- Review of qualification and validation reports- Review of internal quality documents- Monitor and trend vendor performance and maintain key performance indicators for key operational QA activities and services associated with the commercial activities- Support the activities related to Product Quality Complaint Management- 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- 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- Review quality agreements with external parties- Communicate with and manage stakeholders in case of product recall, discontinuation of manufacturing or marketing- Support the Global External Audit Program through the execution of qualification audits and routine GMP audits- Support HA inspection, pre-approval inspections and work with internal stakeholders and external parties to prepare for these inspections- Follow-up of the above audits and inspections and ensure appropriate and timely CAPA implementation- Support the internal audit program- Execute ad hoc quality tasks as relevant to support the international vendor management team- 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:
- 5+ years of experience in a Quality Assurance role, preferably within biopharmaceuticals, with the majority of that time spent in the GMP/GDP area- In-depth knowledge of FDA, PMDA, NMPA, EU regulations and ICH Guidelines- Experience in the Product Quality Complaint Management- Experience with manufacturing and/or lab activities is a plus- Ability to work independently and to make decisions based on experience- Leadership and communication skills, with the ability to influence individuals at all levels- Versatile and flexible working style, also able to independently manage projects and make sound decisions related to product quality issues- Strong technical mastery, analytical and investigation skills- Quality Auditing experience is a bonus- Accurate in execution and reporting, quality-minded- Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines- Able to work effectively together with both internal and external stakeholders.
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