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QA Operations Manager (Contamination Control)(m/w/x)
Ensuring end-to-end GMP compliance for microbial manufacturing assets at a biopharmaceutical leader, authoring critical documentation. Audit experience with Swissmedic/FDA/EMA regulations required. Regular interaction with international regulatory bodies.
Anforderungen
- Degree in Life Sciences or related field
- Experience in GMP-regulated environment, ideally biopharmaceutical
- Proactive, detail-oriented, problem-solving and improvement mindset
- Experience in customer-focused stakeholder management
- Audit experience with Swissmedic/FDA/EMA regulations
- Background in contamination control and monitoring
- Fluency in English; German an asset
Aufgaben
- Lead asset-specific contamination prevention strategies
- Ensure end-to-end compliance across microbial manufacturing
- Author and approve critical GMP documentation
- Review SOPs, deviations, and change controls
- Conduct comprehensive quality risk assessments
- Serve as primary QA expert during inspections
- Manage microbial topics for customer and internal audits
- Partner with cross-functional teams to identify risks
- Drive deviation management and continuous improvement
- Strengthen contamination prevention control practices
- Provide microbiology and QA expertise to stakeholders
- Foster a robust quality culture and operational compliance
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- GMP
- Swissmedic
- FDA
- EMA
Benefits
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic working culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Boni & Prämien
- Performance-based compensation programs
Noch nicht perfekt?
- CH12 Lonza AGVollzeitnur vor OrtSeniorVisp
- Lonza
Microbial Contamination Control Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Vollzeitnur vor OrtSeniorVisp - ten23 health
Senior QMS & Compliance Expert(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Senior QA Specialist, QA Project Management(m/w/x)
Vollzeitnur vor OrtSeniorVisp
QA Operations Manager (Contamination Control)(m/w/x)
Ensuring end-to-end GMP compliance for microbial manufacturing assets at a biopharmaceutical leader, authoring critical documentation. Audit experience with Swissmedic/FDA/EMA regulations required. Regular interaction with international regulatory bodies.
Anforderungen
- Degree in Life Sciences or related field
- Experience in GMP-regulated environment, ideally biopharmaceutical
- Proactive, detail-oriented, problem-solving and improvement mindset
- Experience in customer-focused stakeholder management
- Audit experience with Swissmedic/FDA/EMA regulations
- Background in contamination control and monitoring
- Fluency in English; German an asset
Aufgaben
- Lead asset-specific contamination prevention strategies
- Ensure end-to-end compliance across microbial manufacturing
- Author and approve critical GMP documentation
- Review SOPs, deviations, and change controls
- Conduct comprehensive quality risk assessments
- Serve as primary QA expert during inspections
- Manage microbial topics for customer and internal audits
- Partner with cross-functional teams to identify risks
- Drive deviation management and continuous improvement
- Strengthen contamination prevention control practices
- Provide microbiology and QA expertise to stakeholders
- Foster a robust quality culture and operational compliance
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- GMP
- Swissmedic
- FDA
- EMA
Benefits
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic working culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Boni & Prämien
- Performance-based compensation programs
Über das Unternehmen
Lonza
Branche
Pharmaceuticals
Beschreibung
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Noch nicht perfekt?
- CH12 Lonza AG
QA Contamination Control Manager(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Microbial Contamination Control Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Vollzeitnur vor OrtSeniorVisp - ten23 health
Senior QMS & Compliance Expert(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Senior QA Specialist, QA Project Management(m/w/x)
Vollzeitnur vor OrtSeniorVisp