Sr. Quality Assurance Specialist - Supplier Quality at Vaxcyte, Inc.
San Carlos, CA
About the Job
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
The Senior Quality Assurance (QA) Specialist - Supplier Quality will play a pivotal role in ensuring that all external suppliers and third-party vendors adhere to Vaxcyte’s quality standards and regulatory requirements. This individual will manage supplier audits, evaluate supplier performance, and support the development of quality agreements, ensuring continuous improvement across the supply chain. The ideal candidate will possess in-depth knowledge of cGMP (current Good Manufacturing Practices), regulatory guidelines, and quality management systems, as well as have experience in supplier quality management within the pharmaceutical industry.
Essential Functions:
Requirements:
Reports to: Associate Director, Quality Assurance, Vendor Management
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $123,000 – $134,000
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
The Senior Quality Assurance (QA) Specialist - Supplier Quality will play a pivotal role in ensuring that all external suppliers and third-party vendors adhere to Vaxcyte’s quality standards and regulatory requirements. This individual will manage supplier audits, evaluate supplier performance, and support the development of quality agreements, ensuring continuous improvement across the supply chain. The ideal candidate will possess in-depth knowledge of cGMP (current Good Manufacturing Practices), regulatory guidelines, and quality management systems, as well as have experience in supplier quality management within the pharmaceutical industry.
Essential Functions:
- Supplier Qualification: Manage the supplier qualification process, including risk assessments, review of technical documentation, and evaluation of suppliers' capabilities.
- Supplier Quality Agreements: maintain quality agreements with key suppliers to define quality expectations and responsibilities.
- Supplier Performance Monitoring: Establish and monitor supplier key performance indicators (KPIs), conduct periodic reviews of supplier performance, and provide feedback to drive continuous improvement.
- Change Control: Oversee and assess the impact of changes in supplier processes, materials, and components on product quality. Ensure timely communication and collaboration with internal stakeholders.
- Documentation and Reporting: Maintain accurate and thorough documentation of supplier quality activities, including audit reports, inspection results, and supplier performance metrics.
- Regulatory Compliance: Ensure all supplier-related activities comply with global regulatory requirements, including FDA, EMA, ICH guidelines, and other applicable regulations.
- Cross-functional Collaboration: Work closely with procurement, manufacturing, R&D, and regulatory affairs teams to address supplier-related quality issues and support product development and commercialization.
- Continuous Improvement: Drive improvements in supplier quality management processes by identifying gaps, recommending solutions, and implementing best practices.
Requirements:
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a related field.
- Minimum of 5-7 years of experience in quality assurance, supplier quality, or quality systems management within the pharmaceutical, biotechnology, or life sciences industry.
- Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and other international pharmaceutical quality standards.
- Demonstrated experience managing supplier audits, managing quality agreements, and handling supplier-related CAPAs.
- Excellent problem-solving skills and the ability to manage complex investigations and root cause analyses.
- Strong written and verbal communication skills, with the ability to clearly present audit findings and quality issues to cross-functional teams.
- Certification in quality assurance or auditing (such as ASQ, CQA, or similar) is a plus.
- Ability to travel domestically and internationally (up to 10%).
Reports to: Associate Director, Quality Assurance, Vendor Management
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $123,000 – $134,000