Vaxcyte
Quality Assurance Specialist III, External Manufacturing(m/w/x)
Full-timeOn-siteSenior
Visp
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Competitive compensation package
- Equity component
Other Benefits
- Comprehensive benefits
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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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Competitive Pay
- Competitive compensation package
- Equity component
Other Benefits
- Comprehensive benefits
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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.
Not a perfect match?
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