BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Vollzeitnur vor OrtManagement
Basel
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BEBeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Conducting on-site and remote routine or for-cause audits for cancer-focused clinical trials. Veeva Vault experience for quality management and vendor oversight essential. Coordination of audit schedules and resources.
Anforderungen
- Degree in Life Sciences, Pharmacy, Business, or related field
- Experience in vendor management, clinical operations, GCP auditing, or quality assurance
- Knowledge of GCP, ICH guidelines, and global regulatory requirements
- Experience in GCP compliance, audit readiness, and vendor performance management
- Experience with Veeva Vault for quality management and vendor oversight
- Excellent leadership, communication, analytical, and problem-solving skills
- Ability to manage multiple projects and stakeholders
- Interaction with all levels of the organization
- Proficiency in relevant vendor management systems
- PC literacy and MS Office skills
- Certification in GCP auditing or clinical research
- Experience with eTMF and CTMS
- Familiarity with risk-based quality management principles
- Experience in Veeva Vault Quality Suite implementation
- Flexibility to travel internationally
- Willingness to travel up to 35%
- Ability to perform overnight on-site audits
Aufgaben
- Operationalize approved GCP audit plans and strategies
- Coordinate audit schedules and resources with stakeholders
- Review documentation and quality systems before audits
- Perform on-site and remote routine or for-cause audits
- Evaluate compliance with GCP regulations and guidelines
- Document audit findings, deviations, and non-compliance
- Interview personnel and gather evidence during audits
- Prepare comprehensive audit reports and recommendations
- Ensure timely completion of reports and CAPAs
- Develop robust audit strategies for clinical trial vendors
- Lead vendor audits to identify and resolve gaps
- Maintain inspection readiness for vendor-related activities
- Act as GCP subject matter expert for compliance
- Manage audit findings and documentation in Veeva Vault
- Develop a comprehensive GCP vendor management strategy
- Lead the selection and qualification of clinical vendors
- Establish and maintain strong vendor relationships
- Track vendor onboarding and performance via Veeva Vault
- Oversee contract negotiations, SLAs, and KPIs
- Maintain documentation for qualifications and compliance
- Develop performance metrics and vendor scorecards
- Conduct regular vendor quality assessments
- Resolve performance issues and non-compliance incidents
- Serve as the primary escalation point for vendors
- Partner with cross-functional clinical and regulatory teams
- Lead vendor governance meetings and performance reviews
- Train teams on Veeva Vault for vendor oversight
- Identify and mitigate risks in vendor partnerships
- Drive process improvements for GCP compliance
- Stay updated on regulatory changes and best practices
- Optimize Veeva Vault solutions for management efficiency
- Coach and mentor junior auditors and new staff
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Veeva Vault
- Veeva Vault Quality Suite
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- eTMF
- CTMS
- Vendor management systems
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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BEBeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Conducting on-site and remote routine or for-cause audits for cancer-focused clinical trials. Veeva Vault experience for quality management and vendor oversight essential. Coordination of audit schedules and resources.
Anforderungen
- Degree in Life Sciences, Pharmacy, Business, or related field
- Experience in vendor management, clinical operations, GCP auditing, or quality assurance
- Knowledge of GCP, ICH guidelines, and global regulatory requirements
- Experience in GCP compliance, audit readiness, and vendor performance management
- Experience with Veeva Vault for quality management and vendor oversight
- Excellent leadership, communication, analytical, and problem-solving skills
- Ability to manage multiple projects and stakeholders
- Interaction with all levels of the organization
- Proficiency in relevant vendor management systems
- PC literacy and MS Office skills
- Certification in GCP auditing or clinical research
- Experience with eTMF and CTMS
- Familiarity with risk-based quality management principles
- Experience in Veeva Vault Quality Suite implementation
- Flexibility to travel internationally
- Willingness to travel up to 35%
- Ability to perform overnight on-site audits
Aufgaben
- Operationalize approved GCP audit plans and strategies
- Coordinate audit schedules and resources with stakeholders
- Review documentation and quality systems before audits
- Perform on-site and remote routine or for-cause audits
- Evaluate compliance with GCP regulations and guidelines
- Document audit findings, deviations, and non-compliance
- Interview personnel and gather evidence during audits
- Prepare comprehensive audit reports and recommendations
- Ensure timely completion of reports and CAPAs
- Develop robust audit strategies for clinical trial vendors
- Lead vendor audits to identify and resolve gaps
- Maintain inspection readiness for vendor-related activities
- Act as GCP subject matter expert for compliance
- Manage audit findings and documentation in Veeva Vault
- Develop a comprehensive GCP vendor management strategy
- Lead the selection and qualification of clinical vendors
- Establish and maintain strong vendor relationships
- Track vendor onboarding and performance via Veeva Vault
- Oversee contract negotiations, SLAs, and KPIs
- Maintain documentation for qualifications and compliance
- Develop performance metrics and vendor scorecards
- Conduct regular vendor quality assessments
- Resolve performance issues and non-compliance incidents
- Serve as the primary escalation point for vendors
- Partner with cross-functional clinical and regulatory teams
- Lead vendor governance meetings and performance reviews
- Train teams on Veeva Vault for vendor oversight
- Identify and mitigate risks in vendor partnerships
- Drive process improvements for GCP compliance
- Stay updated on regulatory changes and best practices
- Optimize Veeva Vault solutions for management efficiency
- Coach and mentor junior auditors and new staff
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Veeva Vault
- Veeva Vault Quality Suite
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- eTMF
- CTMS
- Vendor management systems
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.
Über das Unternehmen
BeOne Medicines I GmbH
Branche
Pharmaceuticals
Beschreibung
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Noch nicht perfekt?
- BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Vollzeitnur vor OrtManagementBasel - BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines I GmbH
Associate Director, Distribution Quality(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines I GmbH
Associate Director, Regional Program Lead(m/w/x)
Vollzeitnur vor OrtManagementBasel