Vaxcyte
Senior Manager, Quality Assurance(m/w/x)
Full-timeOn-siteManagement
Visp
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Managing third-party audits and CAPAs for high-fidelity vaccine materials in a clinical-stage setting. In-depth GMP, FDA/EMA, ICH knowledge and significant auditing experience required. Travel for third-party audits expected.
Requirements
- BS or BA with minimum 5 years of Quality Assurance experience
- In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines
- Strong attention to detail
- Significant auditing experience or ASQ certification (CQA, CQE) or auditor certification preferred
- Materials and suppliers’ management experience
- Excellent verbal, written, and interpersonal communication skills
- Experience leading and contributing through influence and working in cross functional teams
- Ability to work in a fast-paced team environment and meet aggressive timelines while prioritizing tasks for multiple projects
- Ability to adapt to changing priorities
- Strong overall knowledge of biologics manufacturing processes and Quality Systems
Tasks
- Perform third-party audits for compliance
- Lead responses to audit observations and implement CAPAs
- Collaborate with Global Vendor Management
- Support the introduction of new suppliers
- Manage materials through Vendor Change Notifications (VCNs)
- Establish Quality Agreements and regulatory documentation
- Represent QA in cross-functional team meetings
- Review and approve compliance documentation
- Develop and maintain procedures for supplier management
- Participate in process improvement projects
- Engage with stakeholders to resolve complex issues
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
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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Managing third-party audits and CAPAs for high-fidelity vaccine materials in a clinical-stage setting. In-depth GMP, FDA/EMA, ICH knowledge and significant auditing experience required. Travel for third-party audits expected.
Requirements
- BS or BA with minimum 5 years of Quality Assurance experience
- In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines
- Strong attention to detail
- Significant auditing experience or ASQ certification (CQA, CQE) or auditor certification preferred
- Materials and suppliers’ management experience
- Excellent verbal, written, and interpersonal communication skills
- Experience leading and contributing through influence and working in cross functional teams
- Ability to work in a fast-paced team environment and meet aggressive timelines while prioritizing tasks for multiple projects
- Ability to adapt to changing priorities
- Strong overall knowledge of biologics manufacturing processes and Quality Systems
Tasks
- Perform third-party audits for compliance
- Lead responses to audit observations and implement CAPAs
- Collaborate with Global Vendor Management
- Support the introduction of new suppliers
- Manage materials through Vendor Change Notifications (VCNs)
- Establish Quality Agreements and regulatory documentation
- Represent QA in cross-functional team meetings
- Review and approve compliance documentation
- Develop and maintain procedures for supplier management
- Participate in process improvement projects
- Engage with stakeholders to resolve complex issues
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
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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