Roche
Head of Compliance and Quality Governance(m/w/x)
Vollzeitnur vor OrtSenior
Kaiseraugst
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
RERevolution Medicines
Executive Director, Head of Quality, Europe(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading European Quality organization for late-stage oncology therapies, aligning with global strategy. 20+ years GxP Quality experience required. Support for transition to commercial operations, serving as primary Quality representative for Europe.
Anforderungen
- Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred)
- 20+ years GxP Quality in pharmaceutical industry
- Track record of building and scaling Quality organizations
- Track record of working in GMP/GDP regulated environment
- Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines)
- Biotech experience
- Significant leadership experience, including managing regional or global teams
Aufgaben
- Lead and develop the European Quality organization
- Align with global quality strategy
- Support transition from clinical to commercial operations
- Serve as primary Quality representative for Europe
- Provide leadership in regional and global governance forums
- Interface with European regulatory authorities
- Ensure Quality oversight of MAH responsibilities
- Manage product complaints and recalls
- Fulfill regulatory commitments with Regulatory Affairs
- Establish and maintain EU Quality Management System
- Ensure compliance with EU GMP, GDP, GCP, and ICH guidelines
- Participate in cross-functional review of Global SOPs
- Harmonize and implement SOPs within EMEA region
- Oversee key quality system processes
- Manage deviations, CAPAs, change control, and risk management
- Monitor QMS performance through KPIs and risk indicators
- Review quality agreements for EU GMP and GDP compliance
- Define and oversee EU QP framework
- Ensure compliant batch certification
- Govern internal and contracted QPs
- Ensure EU GDP compliance
- Oversee distribution activities and wholesale authorizations
- Manage Responsible Person functions
- Provide Quality oversight of external partners
- Monitor performance of CMOs, 3PLs, and distributors
- Lead inspection readiness across Europe
- Manage regulatory inspections and internal/external audits
- Ensure consistent positioning with authorities
- Support regulatory submissions and lifecycle activities
- Oversee quality documentation and CMC components
- Provide Quality leadership for new product introductions
- Ensure readiness for technology transfers and commercial launches
- Collaborate with Regulatory Affairs, Technical Operations, Supply Chain, and Clinical Operations
- Drive a proactive quality culture
- Promote continuous improvement and accountability
Berufserfahrung
- 20 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Revolution Medicines 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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RERevolution Medicines
Executive Director, Head of Quality, Europe(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading European Quality organization for late-stage oncology therapies, aligning with global strategy. 20+ years GxP Quality experience required. Support for transition to commercial operations, serving as primary Quality representative for Europe.
Anforderungen
- Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred)
- 20+ years GxP Quality in pharmaceutical industry
- Track record of building and scaling Quality organizations
- Track record of working in GMP/GDP regulated environment
- Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines)
- Biotech experience
- Significant leadership experience, including managing regional or global teams
Aufgaben
- Lead and develop the European Quality organization
- Align with global quality strategy
- Support transition from clinical to commercial operations
- Serve as primary Quality representative for Europe
- Provide leadership in regional and global governance forums
- Interface with European regulatory authorities
- Ensure Quality oversight of MAH responsibilities
- Manage product complaints and recalls
- Fulfill regulatory commitments with Regulatory Affairs
- Establish and maintain EU Quality Management System
- Ensure compliance with EU GMP, GDP, GCP, and ICH guidelines
- Participate in cross-functional review of Global SOPs
- Harmonize and implement SOPs within EMEA region
- Oversee key quality system processes
- Manage deviations, CAPAs, change control, and risk management
- Monitor QMS performance through KPIs and risk indicators
- Review quality agreements for EU GMP and GDP compliance
- Define and oversee EU QP framework
- Ensure compliant batch certification
- Govern internal and contracted QPs
- Ensure EU GDP compliance
- Oversee distribution activities and wholesale authorizations
- Manage Responsible Person functions
- Provide Quality oversight of external partners
- Monitor performance of CMOs, 3PLs, and distributors
- Lead inspection readiness across Europe
- Manage regulatory inspections and internal/external audits
- Ensure consistent positioning with authorities
- Support regulatory submissions and lifecycle activities
- Oversee quality documentation and CMC components
- Provide Quality leadership for new product introductions
- Ensure readiness for technology transfers and commercial launches
- Collaborate with Regulatory Affairs, Technical Operations, Supply Chain, and Clinical Operations
- Drive a proactive quality culture
- Promote continuous improvement and accountability
Berufserfahrung
- 20 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Revolution Medicines 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
Revolution Medicines
Branche
Pharmaceuticals
Beschreibung
The company is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers.
Noch nicht perfekt?
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