Vaxcyte
Senior Manager, Quality Assurance(m/w/x)
Vollzeitnur vor OrtSenior
Visp
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
VAVaxcyte
Quality Assurance Specialist III, External Manufacturing(m/w/x)
Visp
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Reviewing executed batch records and deviation documents for clinical-stage vaccine innovation. Minimum 5 years QA experience with cGMP and FDA/EMA regulations required. Equity component.
Anforderungen
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or related field
- Minimum 5 years experience in QA, batch record review, manufacturing, or quality systems management
- Other education/experience combinations considered
- Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and pharmaceutical quality standards
- Experience managing batch record review and deviation resolution
- Electronic batch record review experience advantageous
- Great organization skills
- Attention to detail
- In-depth understanding of biologics manufacturing operations
- Ability to prioritize multiple assignments and changing priorities
- Excellent problem-solving skills
- Ability to manage complex investigations and root cause analyses
- Strong written communication skills
- Strong verbal communication skills
- Ability to clearly present quality issues to cross-functional teams
Aufgaben
- Review executed batch records (paper and electronic)
- Review product and program-specific documents
- Approve deviation and change control documents
- Document batch review comments
- Collaborate with cross-functional teams
- Serve as primary QA contact with CDMOs
- Perform product disposition activities
- Review and approve documentation
- Archive documents
- Review raw data
- Support deviations, change controls, and CAPAs
- Participate in investigations and problem resolution
- Resolve conflicts independently
- Participate in technology transfer and validation teams
- Provide QA guidance on procedures and policies
- Review documents for internal and external transfers
- Edit and approve controlled documents
- Maintain accurate quality documentation
- Ensure compliance with global regulatory requirements
- Collaborate with global manufacturing and external vendors
- Address quality issues
- Support product development and commercialization
- Identify gaps in batch record review processes
- Recommend and implement best practices
- Participate in ERP platform implementation
- Support internal audits
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
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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VAVaxcyte
Quality Assurance Specialist III, External Manufacturing(m/w/x)
Visp
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Reviewing executed batch records and deviation documents for clinical-stage vaccine innovation. Minimum 5 years QA experience with cGMP and FDA/EMA regulations required. Equity component.
Anforderungen
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or related field
- Minimum 5 years experience in QA, batch record review, manufacturing, or quality systems management
- Other education/experience combinations considered
- Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and pharmaceutical quality standards
- Experience managing batch record review and deviation resolution
- Electronic batch record review experience advantageous
- Great organization skills
- Attention to detail
- In-depth understanding of biologics manufacturing operations
- Ability to prioritize multiple assignments and changing priorities
- Excellent problem-solving skills
- Ability to manage complex investigations and root cause analyses
- Strong written communication skills
- Strong verbal communication skills
- Ability to clearly present quality issues to cross-functional teams
Aufgaben
- Review executed batch records (paper and electronic)
- Review product and program-specific documents
- Approve deviation and change control documents
- Document batch review comments
- Collaborate with cross-functional teams
- Serve as primary QA contact with CDMOs
- Perform product disposition activities
- Review and approve documentation
- Archive documents
- Review raw data
- Support deviations, change controls, and CAPAs
- Participate in investigations and problem resolution
- Resolve conflicts independently
- Participate in technology transfer and validation teams
- Provide QA guidance on procedures and policies
- Review documents for internal and external transfers
- Edit and approve controlled documents
- Maintain accurate quality documentation
- Ensure compliance with global regulatory requirements
- Collaborate with global manufacturing and external vendors
- Address quality issues
- Support product development and commercialization
- Identify gaps in batch record review processes
- Recommend and implement best practices
- Participate in ERP platform implementation
- Support internal audits
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
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.
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?
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