Daiichi Sankyo Europe
Senior Director DSE Pharmacovigilance Operations (PVOps)(m/w/x)
Vollzeit
Senior
Keine Angabe
München
DA
Daiichi Sankyo Europe1 Monat
Senior Manager PV Quality Management(m/w/x)
Vollzeit
Senior
Keine Angabe
München
Nejo KI-Zusammenfassung
In this role, you will oversee the quality management of pharmacovigilance tasks, ensuring compliance and continuous improvement. Your day-to-day responsibilities will include leading global projects, preparing for audits, and implementing process enhancements to maintain inspection readiness.
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Anforderungen
- •Master's degree in Life Sciences, Pharmacy, or Medical Sciences
- •Experience in audits, inspections, quality management, and CAPAs in GVP
- •Good knowledge of European PV legislation
- •High reliability with accurate operating principles
- •Analytic and systematic approach with good problem-solving skills
- •Ability to understand complex matters with a focus on improvement
- •Substantial communication skills, particularly intercultural
- •Proactive and autonomous working style
- •Effectiveness in working with different functions in a matrixed environment
- •Fluent oral and written communication skills in English
Master-Abschluss
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Monitor quality of PV tasks
- •Ensure compliance with operational standards
- •Lead global projects with the Quality Management Team
- •Implement globally harmonized standards and validated tools
- •Manage non-conformances and CAPA from Quality Events
- •Organize and implement process improvement ideas
- •Prepare for internal audits and inspections
- •Coordinate document requests for audits/inspections
- •Define and maintain quality improvement processes
- •Lead CAPA plan development for audits and quality events
- •Facilitate inspections and audits with QA collaboration
- •Gather global data for assigned KPIs
- •Track CAPA implementation status
- •Present DSE CAPA status to senior leadership
- •Manage inspection readiness projects with SMEs
- •Identify strategies for process improvements
- •Act as main contact for audit and inspection matters
- •Supervise junior staff members as needed
Sprachen
Englisch – verhandlungssicher
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