BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Vollzeitnur vor OrtSenior
Basel
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BEBeOne Medicines USA, Inc.
Senior Manager, Digital Quality Management Systems, Business Analyst(m/w/x)
Basel
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Implementing and managing digital Quality Systems for cancer drug development. GxP compliance and validation expertise required. Hybrid work, 4-day work week option.
Anforderungen
- Bachelor’s degree and 7+ years Life Science, Engineering, Information Systems, or related experience in regulated life sciences environment
- Master’s degree and 5+ years Life Science, Engineering, Information Systems, or related experience in regulated life sciences environment
- Proficiency in Microsoft Office, Smartsheet, Teams, and project management tools
- 7+ years related experience in Quality Systems, project management, and business analysis
- Strong understanding of GxP requirements, Quality System Regulations (QSR), and validation practices
- Proven experience managing enterprise system implementations
- Experience in business administration for Veeva QMS
- Skilled in process modeling, requirements gathering, risk assessment, and stakeholder facilitation
- Excellent interpersonal, communication, and organizational skills
- Lean Six Sigma or Agile certification preferred
Aufgaben
- Support strategy, implementation, and lifecycle management of digital Quality Systems
- Act as liaison between Quality, IT, and business stakeholders
- Ensure technology solutions align with business requirements and goals
- Balance QMS responsibilities with project leadership and process optimization
- Drive GxP compliance and enhance digital maturity
- Serve as business System Owner for assigned GxP digital systems
- Lead system implementations and enhancements lifecycle
- Gather and translate business needs into requirements
- Drive process mapping and continuous improvement initiatives
- Lead digital transformation initiatives across Quality
- Collaborate with QA, IT, Regulatory, Clinical, and vendors
- Align systems with business strategy
- Develop relationships with business process owners
- Ensure systems meet evolving needs
- Plan and lead UAT, training, and change management
- Manage project scope, timeline, resources, and budgets
- Escalate project issues as needed
- Ensure system compliance with GxP, FDA, EMA, and ISO standards
- Prepare and deliver project updates and communications
- Prepare and deliver system documentation
- Oversee governance and configuration of digital quality tools
- Administer digital quality tools like Veeva QMS
- Align digital quality tools with policies and compliance standards
- Optimize system functionality for user experience
- Optimize system functionality for operational efficiency
- Develop and implement master data management practices
- Ensure data accuracy, consistency, and integrity
- Facilitate informed decision-making
- Perform other assigned duties
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Office
- Smartsheet
- Teams
- JIRA
- MS Project
- Veeva Vault
- SAP
- Veeva QMS
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines USA, Inc. 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 USA, Inc.
Senior Manager, Digital Quality Management Systems, Business Analyst(m/w/x)
Basel
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Implementing and managing digital Quality Systems for cancer drug development. GxP compliance and validation expertise required. Hybrid work, 4-day work week option.
Anforderungen
- Bachelor’s degree and 7+ years Life Science, Engineering, Information Systems, or related experience in regulated life sciences environment
- Master’s degree and 5+ years Life Science, Engineering, Information Systems, or related experience in regulated life sciences environment
- Proficiency in Microsoft Office, Smartsheet, Teams, and project management tools
- 7+ years related experience in Quality Systems, project management, and business analysis
- Strong understanding of GxP requirements, Quality System Regulations (QSR), and validation practices
- Proven experience managing enterprise system implementations
- Experience in business administration for Veeva QMS
- Skilled in process modeling, requirements gathering, risk assessment, and stakeholder facilitation
- Excellent interpersonal, communication, and organizational skills
- Lean Six Sigma or Agile certification preferred
Aufgaben
- Support strategy, implementation, and lifecycle management of digital Quality Systems
- Act as liaison between Quality, IT, and business stakeholders
- Ensure technology solutions align with business requirements and goals
- Balance QMS responsibilities with project leadership and process optimization
- Drive GxP compliance and enhance digital maturity
- Serve as business System Owner for assigned GxP digital systems
- Lead system implementations and enhancements lifecycle
- Gather and translate business needs into requirements
- Drive process mapping and continuous improvement initiatives
- Lead digital transformation initiatives across Quality
- Collaborate with QA, IT, Regulatory, Clinical, and vendors
- Align systems with business strategy
- Develop relationships with business process owners
- Ensure systems meet evolving needs
- Plan and lead UAT, training, and change management
- Manage project scope, timeline, resources, and budgets
- Escalate project issues as needed
- Ensure system compliance with GxP, FDA, EMA, and ISO standards
- Prepare and deliver project updates and communications
- Prepare and deliver system documentation
- Oversee governance and configuration of digital quality tools
- Administer digital quality tools like Veeva QMS
- Align digital quality tools with policies and compliance standards
- Optimize system functionality for user experience
- Optimize system functionality for operational efficiency
- Develop and implement master data management practices
- Ensure data accuracy, consistency, and integrity
- Facilitate informed decision-making
- Perform other assigned duties
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Office
- Smartsheet
- Teams
- JIRA
- MS Project
- Veeva Vault
- SAP
- Veeva QMS
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines USA, Inc. 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
BeOne Medicines USA, Inc.
Branche
Pharmaceuticals
Beschreibung
The company is focused on developing strategies to fight cancer through regulatory affairs in diagnostics and medical devices.
Noch nicht perfekt?
- BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines USA, Inc.
Associate Director, Digital Quality Management Systems, Change Management and Digital Adoption(m/w/x)
Vollzeitnur vor OrtManagementBasel - Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel - BeOne Medicines I GmbH
Senior Manager, GCP Inspection Lead(m/w/x)
Vollzeitnur vor OrtSeniorBaselab CHF 141.800 - 177.300 / Jahr - Roche
Digital Quality Strategy Delivery Lead - Pharma Technical Operations(m/w/x)
Vollzeitnur vor OrtManagementBasel