BeOne Medicines I GmbH
Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge(m/w/x)
Vollzeitnur vor OrtSenior
Basel
ab CHF 178.600 - 223.300 / Jahr
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BEBeOne Medicines I GmbH
Associate Director, Product Quality Steward(m/w/x)
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Advancing global quality initiatives and manufacturing strategies for cancer therapies. 5 years managerial experience and leadership skills required. Core QMS product governance tools, APQR, and issue escalation execution.
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Anforderungen
- High motivation and collaboration
- Passionate interest in fighting cancer
- 5 years managerial experience
- Leadership experience (teams, projects, resource allocation)
- Bachelor’s degree
- 6+ years experience in quality sciences, systems, or related regulated industry fields
- Master’s degree preferred
- 8+ years experience preferred
- Strong PC literacy
- MS Office skills (Outlook, Word, Excel, PowerPoint)
- Experience in statistical modeling software
- Advanced degree in life sciences, quality management, or related field
- Extensive experience leading quality investigations
- Extensive experience in quality risk management
- Extensive experience implementing new technologies
- Expertise in quality systems
- Expertise in regulatory requirements (FDA, EMA)
- Expertise in risk management frameworks (ICH Q9)
- Strong leadership skills
- Strong problem-solving skills
- Ability to manage complexity and ambiguity
- Experience developing global training programs
- Experience fostering SME networks
- Proficiency in quality tools and methodologies
- Proficiency in root cause analysis
- Proficiency in Lean
- Proficiency in Six Sigma
- Ability to communicate complex information clearly and effectively across business functions
Aufgaben
- Advance global quality initiatives and manufacturing strategies
- Ensure highest standards of product quality
- Foster expertise in emerging quality technologies
- Contribute to quality improvement through core QMS product governance tools
- Execute change management, APQR, and Issue Escalation/Notice to Management
- Analyze product data trends for proactive patient compliance
- Support cross-functional collaboration
- Drive process improvements
- Enhance organization's approach to quality governance throughout product lifecycle
- Ensure comprehensive root cause analysis for investigations, OOS, and events
- Drive effective CAPA plans
- Collaborate across functions and sites to drive continuous improvement
- Ensure regulatory compliance
- Build a robust knowledge-sharing and risk management culture
- Represent the Quality Organization at platform level
- Participate in molecule level governance meetings and forums
- Serve as Subject Matter Expert for quality risk assessment, investigations, and change control
- Facilitate resolution of complex quality issues
- Review regulatory CMC submission content
- Manage Product Quality Network teams for multiple programs
- Collaborate with R&D, manufacturing (CMC), and regulatory teams
- Ensure quality considerations are embedded in new product development and lifecycle management
- Advise and influence CMC strategies leveraging quality risk management
- Contribute to product quality performance monitoring
- Identify trends and drive improvements
- Lead or participate in cross-functional teams to improve quality systems
- Address systemic challenges
- Support regulatory inspections and audits
- Ensure alignment with global quality standards and best practices
- Perform other related responsibilities as assigned
Berufserfahrung
6 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
MS OfficeOutlookWordExcelPowerPointMintabJMPTableauSciLabLeanSix Sigma
Von Nejo automatisch aufbereitet
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.
Zur Originalanzeige bei BeOne Medicines I GmbHÜber das Unternehmen
BE
PharmaceuticalsBasel
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
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