BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Full-timeOn-siteManagement
Basel
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BEBeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Veeva Vault
- Veeva Vault Quality Suite
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- eTMF
- CTMS
- Vendor management systems
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BEBeOne Medicines I GmbH
Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Veeva Vault
- Veeva Vault Quality Suite
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- eTMF
- CTMS
- Vendor management systems
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
BeOne Medicines I GmbH
Industry
Pharmaceuticals
Description
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Not a perfect match?
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