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Senior Director Quality Transformation and Oversight(m/w/x)
Overseeing GxP-compliant QMS change management for novel drug development. Extensive GxP QA and regulatory experience with large-scale change leadership required. Flexible hours, vacation account.
Anforderungen
- Degree in Life Sciences, Pharmacy, Chemistry, or related field
- Extensive experience in Quality Assurance, GxP compliance, and regulatory environments
- Proven track record of leading large-scale change and transformation projects
- Strong strategic leadership capabilities
- In-depth knowledge of GMP, QMS, and GxP regulations
- Exceptional problem-solving and analytical skills
- Excellent communication and interpersonal skills
- Hands-on approach with ability to navigate strategic challenges
Aufgaben
- Lead critical change and transformation projects
- Develop and implement a global Quality Management Review process
- Drive Quality Management Systems (QMS) and GxP-compliant Change Management processes
- Conduct detailed reviews of strategic and tactical progress
- Collaborate with site and global leaders to ensure alignment with priorities
- Manage key processes impacting patient safety and product quality
- Ensure compliance with GxP regulations
- Drive initiatives to enhance quality standards
- Provide strategic leadership for ongoing GxP and Quality Assurance initiatives
- Support impactful outcomes and successful project execution
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital learning
- Apprenticeships
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance development
- Leadership development
Sonstige Vorteile
- Your voice at the table
- Support for your full potential
Lockere Unternehmenskultur
- Culture on an equal footing
Sinnstiftende Arbeit
- Opportunities to shape & impact
Firmenfahrrad
- Company bike
Öffi Tickets
- Job ticket
- Deutschlandticket
Betriebliche Altersvorsorge
- Employer-funded pension
Kinderbetreuung
- Childcare
Noch nicht perfekt?
- Merck & Co., Inc.Vollzeitnur vor OrtManagementUnterschleißheim
- Merck & Co., Inc., Rahway, NJ, USA
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
Vollzeitnur vor OrtManagementMünchen - Apellis
Senior Director, General Manager(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - HERMES ARZNEIMITTEL GmbH
Leitung Qualitätssicherung(m/w/x)
VollzeitBefristeter Vertragnur vor OrtSeniorPullach im Isartal - Merck & Co., Inc.
Qualified Person als Quality Operations Group Lead Documentation(m/w/x)
VollzeitBefristeter Vertragnur vor OrtSeniorUnterschleißheim
Senior Director Quality Transformation and Oversight(m/w/x)
Overseeing GxP-compliant QMS change management for novel drug development. Extensive GxP QA and regulatory experience with large-scale change leadership required. Flexible hours, vacation account.
Anforderungen
- Degree in Life Sciences, Pharmacy, Chemistry, or related field
- Extensive experience in Quality Assurance, GxP compliance, and regulatory environments
- Proven track record of leading large-scale change and transformation projects
- Strong strategic leadership capabilities
- In-depth knowledge of GMP, QMS, and GxP regulations
- Exceptional problem-solving and analytical skills
- Excellent communication and interpersonal skills
- Hands-on approach with ability to navigate strategic challenges
Aufgaben
- Lead critical change and transformation projects
- Develop and implement a global Quality Management Review process
- Drive Quality Management Systems (QMS) and GxP-compliant Change Management processes
- Conduct detailed reviews of strategic and tactical progress
- Collaborate with site and global leaders to ensure alignment with priorities
- Manage key processes impacting patient safety and product quality
- Ensure compliance with GxP regulations
- Drive initiatives to enhance quality standards
- Provide strategic leadership for ongoing GxP and Quality Assurance initiatives
- Support impactful outcomes and successful project execution
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital learning
- Apprenticeships
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance development
- Leadership development
Sonstige Vorteile
- Your voice at the table
- Support for your full potential
Lockere Unternehmenskultur
- Culture on an equal footing
Sinnstiftende Arbeit
- Opportunities to shape & impact
Firmenfahrrad
- Company bike
Öffi Tickets
- Job ticket
- Deutschlandticket
Betriebliche Altersvorsorge
- Employer-funded pension
Kinderbetreuung
- Childcare
Über das Unternehmen
BioNTech SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Noch nicht perfekt?
- Merck & Co., Inc.
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
Vollzeitnur vor OrtManagementUnterschleißheim - Merck & Co., Inc., Rahway, NJ, USA
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
Vollzeitnur vor OrtManagementMünchen - Apellis
Senior Director, General Manager(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - HERMES ARZNEIMITTEL GmbH
Leitung Qualitätssicherung(m/w/x)
VollzeitBefristeter Vertragnur vor OrtSeniorPullach im Isartal - Merck & Co., Inc.
Qualified Person als Quality Operations Group Lead Documentation(m/w/x)
VollzeitBefristeter Vertragnur vor OrtSeniorUnterschleißheim