1201 F. Hoffmann-La Roche AG
Affiliate Network Regional Quality Lead(m/w/x)
Vollzeit
Berufserfahren
Keine Angabe
Basel
BE
BeOne Medicines I GmbH1 Monat
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Management
Vollzeit
Keine Angabe
Basel
Nejo KI-Zusammenfassung
In this role, you will oversee compliance and quality support for clinical studies, ensuring adherence to regulations while fostering collaboration among teams. Your day-to-day responsibilities will involve identifying compliance issues, leading improvements, and preparing for inspections, all aimed at optimizing clinical operations.
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Anforderungen
- •Expertise in GCP and clinical operations
- •High level of clinical operations knowledge
- •Strong analytical and managerial skills
- •Appropriate escalation of quality issues
- •Excellent English communication and interpersonal skills
- •Excellent organizational, presentation, and training skills
- •Ability to work independently in multi-cultural settings
- •Bachelor’s degree in scientific, medical, or healthcare discipline
- •Minimum 14 years’ experience in GCP compliance or equivalent role
- •Experience in oncology global trials
- •PC literacy and MSOffice skills
Bachelor-Abschluss
Berufserfahrung
14 Jahre
Deine Aufgaben
- •Implement Global Clinical Compliance strategies
- •Provide compliance oversight for assigned studies
- •Ensure inspection readiness and regulatory compliance
- •Identify and escalate non-compliance issues
- •Track non-compliance issues and quality events
- •Support GCP readiness activities and programs
- •Adhere to ICH/GCP and local regulations
- •Contribute to Clinical Operations Work Instructions and SOPs
- •Demonstrate clinical study experience and trial management
- •Support inspection preparation and response management
- •Lead and guide Regional Clinical Compliance stakeholders
- •Foster collaboration with key stakeholders
- •Draft responses and corrective action plans for audits
- •Identify compliance matters and drive improvements
- •Provide GCP compliance guidance to stakeholders
- •Ensure escalation of GCP non-compliance issues
- •Develop and implement CAPA for compliance issues
- •Manage Site & Sponsor inspections
- •Develop GCP inspection readiness programs
- •Feed audit findings into training materials
- •Approve compliance visit scheduling and preparation
- •Peer review compliance assessment reports
- •Monitor Key Compliance Indicators and develop metrics
- •Conduct trend analysis for compliance risks
- •Establish preventive action initiatives
- •Drive internal GCP compliance process improvements
- •Lead GCP compliance training material development
- •Provide expertise on clinical trial processes
- •Offer feedback on investigator site performance
- •Stay updated on regulations and industry trends
- •Oversee direct/indirect reports' work
- •Conduct regular performance appraisals and feedback
- •Engage in career development planning for team members
- •Mentor Clinical Compliance team members
Tools & Technologien
MSOffice
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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