Vaxcyte
Quality Assurance Specialist III, External Manufacturing(m/w/x)
Vollzeitnur vor OrtSenior
Visp
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VAVaxcyte
Senior Manager, Quality Assurance(m/w/x)
Visp
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
QA leadership for drug substance intermediates and custom raw materials at a clinical-stage vaccine company. 8 years of QA experience with GMPs and FDA/EMA regulations required. Equity component, comprehensive benefits.
Anforderungen
- BS or BA with 8 years of Quality Assurance experience or comparable education/experience
- In-depth knowledge of GMPs, FDA/EMA regulations, ICH guidelines
- Strong attention to detail
- Knowledge in clinical and commercial product desired
- Excellent verbal, written, interpersonal communication skills
- Experience leading and contributing through influence
- Experience working in cross-functional teams
- Ability to work in fast-paced team environment
- Ability to meet aggressive timelines
- Ability to prioritize tasks for multiple projects
- Ability to adapt to changing priorities
- Strong overall knowledge of biologics manufacturing processes
- Strong overall knowledge of Quality Systems
- Experience with good documentation practices
- Experience with technical writing
- Experience with cGMP standards
Aufgaben
- Lead QA for Drug Substance intermediates and custom raw materials
- Ensure CMO operations meet Vaxcyte’s quality and regulatory standards
- Represent QA in internal and external cross-functional team meetings
- Review and approve deviations, risk assessments, change controls, and CAPAs
- Conduct thorough QA reviews of CMO batch records
- Review and manage disposition packages for Drug Substance intermediates and raw materials
- Develop and maintain QA procedures and policies
- Drive timely resolution of quality issues with CMOs
- Escalate significant risks to Vaxcyte management
- Guide supplier manufacturing investigations
- Support technology transfer activities and document reviews
- Participate in process improvement projects
- Collaborate with stakeholders to solve complex issues
- Promote quality standards of excellence
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Competitive compensation package
- Equity component
Sonstige Vorteile
- Comprehensive benefits
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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VAVaxcyte
Senior Manager, Quality Assurance(m/w/x)
Visp
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
QA leadership for drug substance intermediates and custom raw materials at a clinical-stage vaccine company. 8 years of QA experience with GMPs and FDA/EMA regulations required. Equity component, comprehensive benefits.
Anforderungen
- BS or BA with 8 years of Quality Assurance experience or comparable education/experience
- In-depth knowledge of GMPs, FDA/EMA regulations, ICH guidelines
- Strong attention to detail
- Knowledge in clinical and commercial product desired
- Excellent verbal, written, interpersonal communication skills
- Experience leading and contributing through influence
- Experience working in cross-functional teams
- Ability to work in fast-paced team environment
- Ability to meet aggressive timelines
- Ability to prioritize tasks for multiple projects
- Ability to adapt to changing priorities
- Strong overall knowledge of biologics manufacturing processes
- Strong overall knowledge of Quality Systems
- Experience with good documentation practices
- Experience with technical writing
- Experience with cGMP standards
Aufgaben
- Lead QA for Drug Substance intermediates and custom raw materials
- Ensure CMO operations meet Vaxcyte’s quality and regulatory standards
- Represent QA in internal and external cross-functional team meetings
- Review and approve deviations, risk assessments, change controls, and CAPAs
- Conduct thorough QA reviews of CMO batch records
- Review and manage disposition packages for Drug Substance intermediates and raw materials
- Develop and maintain QA procedures and policies
- Drive timely resolution of quality issues with CMOs
- Escalate significant risks to Vaxcyte management
- Guide supplier manufacturing investigations
- Support technology transfer activities and document reviews
- Participate in process improvement projects
- Collaborate with stakeholders to solve complex issues
- Promote quality standards of excellence
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Attraktive Vergütung
- Competitive compensation package
- Equity component
Sonstige Vorteile
- Comprehensive benefits
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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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?
- VaxcyteQuality Assurance Specialist III, External Manufacturing(m/w/x)Vollzeitnur vor OrtSeniorVisp
- VaxcyteStaff Engineer, Drug Substance, MSAT(m/w/x)Vollzeitnur vor OrtSeniorVisp
- ten23 healthHead of Quality & GMP Operations(m/w/x)Vollzeitnur vor OrtSeniorVisp
- LonzaSenior QA Specialist, Microbial Contamination Control & Cleaning(m/w/x)Vollzeitnur vor OrtSeniorVisp
- LonzaSenior QA Specialist - QA Projects(m/w/x)Vollzeitnur vor OrtManagementVisp