BioNTech SE
Manager QA Compliance(m/w/x)
Vollzeitnur vor OrtSenior
Mainz
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BOBoehringer Ingelheim
Senior Corporate Quality Manager / Quality Audits & Inspections(m/w/x)
Ingelheim am Rhein, Biberach
VollzeitVor OrtSenior
AI/ML
Nejo KI-Zusammenfassung
Global quality audits of pharma sites and CMOs, assessing GxP standards. Bachelor's degree and long-term GMP experience required. On-site audits, 4-day work week.
Anforderungen
- Bachelor's, Master's, or Doctoral degree in Pharmaceutics, Biopharmaceutics, Engineering, or Science
- Long-term practical experience in GMP-regulated environments (Quality Control, Manufacturing, Engineering, Drug Development)
- Experience in Quality Assurance or regulatory compliance management
- Strong knowledge of GxP, ISO, CSV, and regulatory compliance regulations
- Exposure to authority inspections (FDA, EMA, USDA or international)
- Experience in matrix organizations
- Demonstrated audit skills with appropriate qualifications
- Ability to identify and resolve GxP-related issues
- Adherence to company and regulatory standards
- Proficiency in data analytics, including AI
- Strategic and conceptual thinking
- Cross-functional and cross-country collaboration
- Ability to drive compliance initiatives and programs
- English proficiency with excellent written and oral communication
- German or French language skills (advantageous)
- Applications from persons with severe disabilities warmly welcomed
Aufgaben
- Schedule, prepare, conduct, and report on global quality audits
- Audit Boehringer Ingelheim sites, global functions, and processes
- Audit Contract Manufacturing Organizations (CMOs)
- Perform regular, for-cause, and mock-PAI audits
- Assess implementation of Boehringer Ingelheim’s quality and GxP standards
- Ensure compliance with regulatory requirements
- Identify, communicate, and escalate compliance issues and risks
- Establish and ensure adequate CAPA plans post-audit
- Verify effective implementation of CAPAs during subsequent audits
- Monitor industry trends and regulatory agency interpretations
- Stay updated with evolving global GxP standards
- Provide insights and guidance on GxP requirements
- Lead or contribute to project teams for compliance improvement
- Define and maintain components of the Quality Audit and Inspection System
- Ensure system alignment with best practices
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
Tools & Technologien
- GxP
- ISO
- CSV
- FDA
- EMA
- USDA
- AI
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Boehringer Ingelheim 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.
Noch nicht perfekt?
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BOBoehringer Ingelheim
Senior Corporate Quality Manager / Quality Audits & Inspections(m/w/x)
Ingelheim am Rhein, Biberach
VollzeitVor OrtSenior
AI/ML
Nejo KI-Zusammenfassung
Global quality audits of pharma sites and CMOs, assessing GxP standards. Bachelor's degree and long-term GMP experience required. On-site audits, 4-day work week.
Anforderungen
- Bachelor's, Master's, or Doctoral degree in Pharmaceutics, Biopharmaceutics, Engineering, or Science
- Long-term practical experience in GMP-regulated environments (Quality Control, Manufacturing, Engineering, Drug Development)
- Experience in Quality Assurance or regulatory compliance management
- Strong knowledge of GxP, ISO, CSV, and regulatory compliance regulations
- Exposure to authority inspections (FDA, EMA, USDA or international)
- Experience in matrix organizations
- Demonstrated audit skills with appropriate qualifications
- Ability to identify and resolve GxP-related issues
- Adherence to company and regulatory standards
- Proficiency in data analytics, including AI
- Strategic and conceptual thinking
- Cross-functional and cross-country collaboration
- Ability to drive compliance initiatives and programs
- English proficiency with excellent written and oral communication
- German or French language skills (advantageous)
- Applications from persons with severe disabilities warmly welcomed
Aufgaben
- Schedule, prepare, conduct, and report on global quality audits
- Audit Boehringer Ingelheim sites, global functions, and processes
- Audit Contract Manufacturing Organizations (CMOs)
- Perform regular, for-cause, and mock-PAI audits
- Assess implementation of Boehringer Ingelheim’s quality and GxP standards
- Ensure compliance with regulatory requirements
- Identify, communicate, and escalate compliance issues and risks
- Establish and ensure adequate CAPA plans post-audit
- Verify effective implementation of CAPAs during subsequent audits
- Monitor industry trends and regulatory agency interpretations
- Stay updated with evolving global GxP standards
- Provide insights and guidance on GxP requirements
- Lead or contribute to project teams for compliance improvement
- Define and maintain components of the Quality Audit and Inspection System
- Ensure system alignment with best practices
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
Tools & Technologien
- GxP
- ISO
- CSV
- FDA
- EMA
- USDA
- AI
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Boehringer Ingelheim 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.
Über das Unternehmen
Boehringer Ingelheim
Branche
Pharmaceuticals
Beschreibung
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
Noch nicht perfekt?
- BioNTech SE
Manager QA Compliance(m/w/x)
Vollzeitnur vor OrtSeniorMainz - Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NCE(m/w/x)
Vollzeitnur vor OrtSeniorBiberach, Ingelheim am Rhein - Boehringer Ingelheim
.CMO Quality Assurance Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenIngelheim am Rhein - BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
.Manager Global Quality Assurance CSV(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz