Vaxcyte
Vaxcyte is a biotechnology company focused on developing innovative vaccines to combat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Utilizing advanced chemistry and synthetic techniques, Vaxcyte aims to improve upon existing vaccines with products like their VAX-24 and VAX-31 pneumococcal conjugate vaccines, which target a broad range of bacterial strains. Vaxcyte's approach includes re-engineering the vaccine-making process through the XpressCF™ cell-free protein synthesis platform, aiming to create vaccines that effectively counter bacteria's complex defense mechanisms while maintaining immunogenicity. Their pipeline includes several high-fidelity, broad-spectrum vaccine candidates designed to address significant public health challenges and prevent bacterial infections worldwide.
Senior CAPA Manager - Clinical Quality Assurance
February 27
🏄 California – Remote
💵 $158k - $185k / year
⏰ Full Time
🟠 Senior
🔧 QA Engineer (Quality Assurance)
🦅 H1B Visa Sponsor
Vaxcyte
Vaxcyte is a biotechnology company focused on developing innovative vaccines to combat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Utilizing advanced chemistry and synthetic techniques, Vaxcyte aims to improve upon existing vaccines with products like their VAX-24 and VAX-31 pneumococcal conjugate vaccines, which target a broad range of bacterial strains. Vaxcyte's approach includes re-engineering the vaccine-making process through the XpressCF™ cell-free protein synthesis platform, aiming to create vaccines that effectively counter bacteria's complex defense mechanisms while maintaining immunogenicity. Their pipeline includes several high-fidelity, broad-spectrum vaccine candidates designed to address significant public health challenges and prevent bacterial infections worldwide.
📋 Description
• Join our Mission to Protect Humankind! • Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. • We address serious health issues from infections such as pneumococcal disease and Group A Strep. • Our core values include rethinking convention, aiming high, leading with heart, and modeling excellence. • Seeking a Senior CAPA Manager, Clinical Quality Assurance to ensure compliance with regulatory requirements. • Ideal candidates will have a strong background in quality management within a clinical setting.
🎯 Requirements
• BA or BS in related field. • Minimum of 9 years of experience in Quality Assurance within the clinical or pharmaceutical industry. • Knowledge of QMS system (Veeva preferred). • GCP QA Certification preferred (RQAP-GCP, or similar). • Experience across all phases of clinical development. • Knowledge of applicable FDA regulations and ICH guidelines. • Proficiency in QA tools and software (Veeva preferred). • Excellent communication and interpersonal skills, with the ability to work collaboratively with diverse teams. • Strong analytical and problem-solving skills, with a keen attention to detail.
🏖️ Benefits
• Comprehensive benefits • Equity component
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