Vaxcyte
Manager, Quality Assurance(m/w/x)
Full-timeOn-siteSenior
Visp
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VAVaxcyte
Senior Manager, Quality Assurance(m/w/x)
Visp
Full-timeOn-siteManagement
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMPs
- FDA/EMA regulations
- ICH guidelines
- cGMP standards
- Quality Systems
Benefits
Competitive Pay
- Equity component
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Vaxcyte and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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VAVaxcyte
Senior Manager, Quality Assurance(m/w/x)
Visp
Full-timeOn-siteManagement
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- GMPs
- FDA/EMA regulations
- ICH guidelines
- cGMP standards
- Quality Systems
Benefits
Competitive Pay
- Equity component
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Vaxcyte and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Vaxcyte
Industry
Pharmaceuticals
Description
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases.
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