Quality Management System:
Implement and maintain the local Quality System in the areas within scope, in accordance with the Novartis
Quality Manual, the CO Quality Plan, and the local regulatory requirements through:
• Implementation of global quality documents in the Japan CO
• Contribution to the CO Quality Plan preparation, implementation and follow-up
• Contribution to the Quality Risk Assessments
• Management of local quality documents
Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with
Report monthly Key Quality Indicators (KQIs) within scope of responsibilities.
Contribute to ESP (External Service Providers) assessment for local outsourced clinical
development/pharmacovigilance/post-marketing surveillance activities and provide guidance and oversee
ESP and POP (Patient Oriented Programs) activities in the CO through interactions with the line-functions
and stakeholders involved according to current SOPs.
Assist the Marketing Program Owners (MPOs) in developing the CAPA Plan to correct any deficiencies
identified during the POP vendor assessment and sign the CAPA plan.
Provide guidance for the preparation, conduct and follow-up of GCP and Pharmacovigilance related audits,
at vendors and at investigator sites.
Ensure the preparation, facilitate the conduct and coordinate the follow-up of GCP and Pharmacovigilance
related local and foreign Health Authority inspections at the CO, at vendors and at investigator sites.
7. Quality Issues Management:
Ensure that deviations and issues are properly managed in AQWA including the respect of the escalation
Contribute to trainings in the areas within scope
• Reviewing training materials
• Providing/supporting Quality trainings
100% timely delivery of all training requirements including compliance
Diversity & Inclusion / EEO
Education: • Degree in Life Sciences or related fields
• Min. 3 years’ experience in the pharmaceutical industry in a
relevant field such as quality assurance, regulatory affairs,
pharmacovigilance, clinical development or a directly related area
English Skill: • Minimum in speaking and writing