Vaxcyte
Manager, Quality Assurance(m/w/x)
Vollzeitnur vor OrtSenior
Visp
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VAVaxcyte
Senior Manager, Quality Assurance(m/w/x)
Visp
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Overseeing compliance for vaccine conjugation and drug substance manufacturing. 10+ years QA experience with in-depth GMP, FDA/EMA, ICH knowledge required. Equity component included.
Anforderungen
- BS or BA degree
- At least 10 years Quality Assurance experience
- In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines
- Strong attention to detail
- Knowledge in clinical and commercial product (desired)
- Excellent verbal, written, and interpersonal communication skills
- Experience leading through influence and cross-functional teamwork
- Ability to prioritize tasks in fast-paced environments
- Ability to adapt to changing priorities
- Knowledge of biologics manufacturing and Quality Systems
- Experience with good documentation practices and cGMP standards
- Equivalent combination of education or experience
Aufgaben
- Lead quality assurance for conjugation and drug substance manufacturing
- Ensure CMO operations meet quality standards and regulatory requirements
- Represent QA in internal and external cross-functional teams
- Oversee deviations, investigations, risk assessments, and CAPAs
- Review and approve internal and external compliance documentation
- Perform detailed QA reviews of CMO-executed batch records
- Review disposition packages for global regulatory compliance
- Develop and maintain QA procedures and policies
- Drive resolution of quality issues with contract manufacturers
- Escalate quality risks to the company's management
- Provide expert guidance on supplier manufacturing investigations
- Support technology transfer activities and review related documents
- Lead and participate in process improvement projects
- Collaborate with stakeholders to resolve complex quality issues
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMPs
- FDA/EMA regulations
- ICH guidelines
- cGMP standards
- Quality Systems
Benefits
Attraktive Vergütung
- Equity component
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Vaxcyte 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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- ten23 health
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VAVaxcyte
Senior Manager, Quality Assurance(m/w/x)
Visp
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Overseeing compliance for vaccine conjugation and drug substance manufacturing. 10+ years QA experience with in-depth GMP, FDA/EMA, ICH knowledge required. Equity component included.
Anforderungen
- BS or BA degree
- At least 10 years Quality Assurance experience
- In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines
- Strong attention to detail
- Knowledge in clinical and commercial product (desired)
- Excellent verbal, written, and interpersonal communication skills
- Experience leading through influence and cross-functional teamwork
- Ability to prioritize tasks in fast-paced environments
- Ability to adapt to changing priorities
- Knowledge of biologics manufacturing and Quality Systems
- Experience with good documentation practices and cGMP standards
- Equivalent combination of education or experience
Aufgaben
- Lead quality assurance for conjugation and drug substance manufacturing
- Ensure CMO operations meet quality standards and regulatory requirements
- Represent QA in internal and external cross-functional teams
- Oversee deviations, investigations, risk assessments, and CAPAs
- Review and approve internal and external compliance documentation
- Perform detailed QA reviews of CMO-executed batch records
- Review disposition packages for global regulatory compliance
- Develop and maintain QA procedures and policies
- Drive resolution of quality issues with contract manufacturers
- Escalate quality risks to the company's management
- Provide expert guidance on supplier manufacturing investigations
- Support technology transfer activities and review related documents
- Lead and participate in process improvement projects
- Collaborate with stakeholders to resolve complex quality issues
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- GMPs
- FDA/EMA regulations
- ICH guidelines
- cGMP standards
- Quality Systems
Benefits
Attraktive Vergütung
- Equity component
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Vaxcyte 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
Vaxcyte
Branche
Pharmaceuticals
Beschreibung
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases.
Noch nicht perfekt?
- Vaxcyte
Manager, Quality Assurance(m/w/x)
Vollzeitnur vor OrtSeniorVisp - ten23 health
Head of Quality & GMP Operations(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist/QA Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Senior QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Head of QA Mammalian(m/w/x)
Vollzeitnur vor OrtSeniorVisp