Dein persönlicher KI-Karriere-Agent
Senior Director Global Quality Excellence and Oversight(m/w/x)
Developing global Quality Management Review and GxP-compliant change processes for a biotechnology firm. Extensive GxP compliance and regulatory experience required. Flexible hours, vacation account, digital learning.
Anforderungen
- Degree in Life Sciences, Pharmacy, Chemistry, or related field
- Advanced degrees (MSc, PhD, MBA) are a plus
- Extensive experience in Quality Assurance
- Extensive experience in GxP compliance
- Extensive experience in regulatory environments (pharmaceutical industry)
- Proven track record leading large-scale change projects
- Proven track record leading large-scale transformation projects
- Strong strategic leadership capabilities
- Ability to inspire cross-functional teams
- Ability to guide cross-functional teams (global and site-specific)
- In-depth knowledge of GMP
- In-depth knowledge of QMS
- In-depth knowledge of GxP regulations
- Experience with Change Management processes
- Exceptional problem-solving skills
- Exceptional analytical skills
- Ability to manage complex projects
- Ability to drive data-driven decision-making
- Excellent communication skills
- Excellent interpersonal skills
- Ability to collaborate effectively with stakeholders
- Hands-on approach
- Ability to navigate strategic challenges
- Ability to navigate dynamic environments
- Ability to navigate fast-paced environments
Aufgaben
- Lead global Quality Management Review development
- Implement comprehensive Quality Management Systems
- Drive GxP-compliant Change Management processes
- Conduct detailed strategic and tactical progress reviews
- Collaborate with site and global leaders on milestones
- Ensure alignment with regulatory and organizational goals
- Manage processes impacting patient safety and product quality
- Ensure GxP regulatory compliance
- Enhance quality standards on business and GxP levels
- Support ongoing GxP and Quality Assurance initiatives
- Combine strategic oversight with hands-on contributions
- Ensure 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
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Apprenticeships
- Support for your full potential
Startup-Atmosphäre
- Voice at the table
Lockere Unternehmenskultur
- Culture on an equal footing
Sinnstiftende Arbeit
- Opportunities to shape and impact
Firmenfahrrad
- Company bike
Öffi Tickets
- Job ticket
- Deutschlandticket
Betriebliche Altersvorsorge
- Employer-funded pension
Kinderbetreuung
- Childcare
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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Senior Director Global Quality Excellence and Oversight(m/w/x)
Developing global Quality Management Review and GxP-compliant change processes for a biotechnology firm. Extensive GxP compliance and regulatory experience required. Flexible hours, vacation account, digital learning.
Anforderungen
- Degree in Life Sciences, Pharmacy, Chemistry, or related field
- Advanced degrees (MSc, PhD, MBA) are a plus
- Extensive experience in Quality Assurance
- Extensive experience in GxP compliance
- Extensive experience in regulatory environments (pharmaceutical industry)
- Proven track record leading large-scale change projects
- Proven track record leading large-scale transformation projects
- Strong strategic leadership capabilities
- Ability to inspire cross-functional teams
- Ability to guide cross-functional teams (global and site-specific)
- In-depth knowledge of GMP
- In-depth knowledge of QMS
- In-depth knowledge of GxP regulations
- Experience with Change Management processes
- Exceptional problem-solving skills
- Exceptional analytical skills
- Ability to manage complex projects
- Ability to drive data-driven decision-making
- Excellent communication skills
- Excellent interpersonal skills
- Ability to collaborate effectively with stakeholders
- Hands-on approach
- Ability to navigate strategic challenges
- Ability to navigate dynamic environments
- Ability to navigate fast-paced environments
Aufgaben
- Lead global Quality Management Review development
- Implement comprehensive Quality Management Systems
- Drive GxP-compliant Change Management processes
- Conduct detailed strategic and tactical progress reviews
- Collaborate with site and global leaders on milestones
- Ensure alignment with regulatory and organizational goals
- Manage processes impacting patient safety and product quality
- Ensure GxP regulatory compliance
- Enhance quality standards on business and GxP levels
- Support ongoing GxP and Quality Assurance initiatives
- Combine strategic oversight with hands-on contributions
- Ensure 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
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Apprenticeships
- Support for your full potential
Startup-Atmosphäre
- Voice at the table
Lockere Unternehmenskultur
- Culture on an equal footing
Sinnstiftende Arbeit
- Opportunities to shape and impact
Firmenfahrrad
- Company bike
Öffi Tickets
- Job ticket
- Deutschlandticket
Betriebliche Altersvorsorge
- Employer-funded pension
Kinderbetreuung
- Childcare
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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?
- 3166 Intervet International Gm
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Senior Director, General Manager(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - Merck & Co., Inc., Rahway, NJ, USA
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
Vollzeitnur vor OrtManagementMünchen - Merck & Co., Inc.
Qualified Person als Quality Operations Group Lead Compliance(m/w/x)
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