Inspection Manager
il y a 2 jours
Reports to: Head of Preclinical Quality & GxP audits and inspections
Main Responsibilities
- As argenx can face health authority inspections in all locations were argenx is present and has operational activities ongoing; cross functional global collaboration with multiple teams is key to ensure that inspection activities are planned and executed in accordance with internal procedures in order to maintain argenx inspection ready at all times.
- Deliver planning for inspection readiness activities, inspection management training, developing, and maintaining inspection management processes and development of inspection management tools and systems. Facilitate the needs of the inspection team for health authority inspections. Provide continuous awareness to argenx employees on inspection related matters, as and when needed.
- Provide through partnership with argenx Quality and related operational teams on health authority inspection and mock matters. Working with Global Quality, facilitate inspection readiness, requests for information/documentation, and inspection response activities. To stay on top of all inspection-related requests/actions/observations in order to streamline responses throughout different inspections.
- Maintain prediction of inspections and report status of health authority inspections. This includes reporting inspection activity, findings/observations, metrics, and relevant insights such as inspection history, SAE, etc. Assist in the preparation of inspection risk assessments for senior management and key stakeholders so they are apprised key risk prior to an inspection and that appropriate corrective action plans are implemented in a timely manner.
Desired Skills & Experience
- Pharmaceutical background preferred with strong knowledge of the global health authority regulations (e.g., FDA, EMA, PMDA); local requirements and GxP.
- Knowledge and experience of inspection management processes with ability to drive inspection preparedness and response actions.
- Strong communication, organization and networking skills.
- Excellence in leadership.
- 8+ years of experience in quality & compliance activities including audit and inspection support.
- 5+ years of experience in regulated industry or equivalent.
- Ability to travel up to 25%.
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