---
title: 'Executive Director Quality Assurance, External Manufacturing at Vaxcyte'
canonical: 'https://feeny.ai/job/executive-director-quality-assurance-external-manufacturing-vaxcyte-san-carlos-z4sv4mf49dhd'
type: 'job'
last_seen: '2026-09-14'
---

# Executive Director Quality Assurance, External Manufacturing at Vaxcyte

- **Company:** Vaxcyte
- **Location:** San Carlos California, United States
- **Posted:** 2026-05-29
- **Last confirmed live:** 2026-09-14
- **Apply:** https://boards.greenhouse.io/vaxcyte/jobs/5231879008?gh_jid=5231879008

## Job description

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, 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 Executive Director, Quality Assurance, External Manufacturing is responsible for leading the External Manufacturing Quality function and executing the quality strategy across Vaxcyte’s global network of Contract Development and Manufacturing Organizations (CDMOs) and external partners. In a highly outsourced operating model, this role ensures that externally executed GMP activities are compliant with global regulatory requirements and Vaxcyte quality standards, supporting product quality, supply continuity, and regulatory readiness.

This leader drives a proactive, risk-based quality approach and implements scalable systems, governance, and partnerships to enable operational excellence across the external network, supporting clinical development, BLA readiness, and commercial supply. The Executive Director owns external quality performance and operational decision-making within the function, while escalating critical risks and aligning with VP-level strategy. This role requires strong cross-functional leadership and the ability to influence internal and external stakeholders in a highly matrixed environment.

Essential Functions:

- Own quality performance across the external network, ensuring compliance, supply continuity, and effective management of quality risk, with escalation of critical risks to VP-level as appropriate.
- Provide end-to-end QA leadership for externally executed GxP activities, including manufacturing and release of drug substance, drug product, components, and critical raw materials.
- Serve as the senior QA leader for external operations, representing Quality in cross-functional and executive forums, and influencing decisions across Technical Operations, CMC, Regulatory, and Supply Chain.
- Establish and maintain strategic partnerships with external partners, driving accountability, performance management, and continuous improvement.
- Lead quality governance across the external network, including KPIs, escalation pathways, and risk-based oversight models focused on critical processes and high-risk partners.
- Oversee and drive resolution of complex, cross-organizational quality issues, ensuring robust investigations, root cause analysis, and sustainable CAPAs.
- Provide oversight and decision authority for batch disposition and product release, ensuring timely, compliant supply of clinical and commercial materials.
- Drive inspection readiness across the external network, including PAI and global health authority inspections, and serve as a key QA representative during inspections.
- Provide strategic QA leadership for technology transfer, process validation, and lifecycle management across external sites.
- Build, lead, and develop a high-performing External Quality organization, including talent development, succession planning, and organizational scalability.
- Champion a strong quality culture across internal teams and external partners, reinforcing accountability, transparency, and continuous improvement.

Requirements:

BS/BA required, with a minimum of 16 years of progressive experience in Quality Assurance within biopharmaceuticals, including significant leadership in external manufacturing and CDMO oversight, vaccines experience desirable. Other combinations of education and/or experience may be considered.

- Deep expertise in GMP regulations, FDA and global regulatory expectations, and ICH guidelines
- Extensive experience operating within a highly outsourced/CDMO-based manufacturing model
- Proven track record of leading complex external quality networks, driving performance and outcomes without direct authority
- Strong experience supporting technology transfer, process validation, and lifecycle management across multiple external sites
- Demonstrated success in inspection readiness and regulatory inspections, including pre-approval inspections (PAIs)
- Experience establishing governance frameworks, and performance metrics for external partners
- Strong background in risk management and quality systems, with the ability to apply risk-based decision-making in a GxP environment
- Proven ability to influence at the executive level, driving alignment across cross-functional teams and external partners
- Demonstrated experience building, leading, and scaling high-performing teams in a complex, fast-paced environment
- Strong business acumen, with the ability to balance quality, compliance, and supply continuity to support clinical and commercial objectives

## Key Competencies

- Strategic Leadership in Outsourced Models
- External Partner Governance & Influence
- Risk-Based Quality Oversight
- Regulatory Inspection Readiness (PAI Focus)
- Executive Communication & Cross-Functional Leadership
- Complex Problem Solving & Decision-Making
- Organizational Development & Talent Leadership

Reports to: Vice President, Quality Assurance

Location: San Carlos, CA

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):

Hybrid (minimum of 3 days per week onsite)

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $300,000 - $350,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Relocation:

This role is not eligible for relocation assistance.

## #LI-JN1

## Equal Opportunity

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Recruitment Fraud Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at [vaxcyte.com/careers](https://vaxcyte.com/careers/).

## About Vaxcyte

## Company Overview
- **One-liner**: Vaxcyte is a clinical-stage biotechnology company re-engineering how vaccines are made to eliminate bacterial infections, using a cell-free protein synthesis platform to develop high-fidelity, broad-spectrum vaccines.
- **Entity Type**: Public (Ticker: PCVX)
- **Headquarters**: San Carlos, California, United States
- **Founded**: 2013 (as SutroVax; rebranded to Vaxcyte in 2020)
- **Founders**: Not publicly available (the company emerged from Sutro Biopharma’s spin-out)

## Core Business
- **Primary industry**: Biotechnology / Vaccines (Infectious Disease)
- **Target customers**: Global healthcare systems, public health organizations, and ultimately patients (B2B/Institutional); the company develops vaccines for both pediatric and adult populations.
- **Mission or purpose**: To protect humankind from the consequences of bacterial infections, eliminating diseases like invasive pneumococcal disease, Group A Strep, and Shigella.

## Products & Services
- **VAX-31 (31-valent PCV)**: A broad-spectrum pneumococcal conjugate vaccine candidate in Phase 3 for adults and Phase 2 for infants. Designed to cover over 95% of circulating IPD serotypes in U.S. adults 50+ and ~94% in infants. FDA Breakthrough Therapy designation granted.
- **VAX-24 (24-valent PCV)**: A pneumococcal conjugate vaccine candidate in Phase 2 for infants, designed to cover more serotypes than any infant PCV on the market today.
- **VAX-A1 (Group A Strep)**: A preclinical conjugate vaccine candidate for Group A Strep, a disease with no currently approved vaccine. Phase 1 first-in-human study (adults) underway in Australia.
- **VAX-GI (Shigella)**: A novel preclinical vaccine candidate targeting Shigella, a leading cause of diarrheal disease.
- **Platform Technology**: A proprietary cell-free protein synthesis platform that enables site-specific, carrier-sparing conjugation to produce precisely targeted vaccines with enhanced immunogenicity.

## Market Standing
- **Valuation/Market Cap**: ~$16.7 billion (as of early July 2026)
- **Key Metric**: Total funding raised (private) is not applicable; as a public company, key metrics include cash position (~$2.0 billion as of Q1 2026) and R&D investment. The company is pre-revenue.
- **Notable Investors/Partners**: Major institutional investors include Baker Bros. Advisors, Fidelity, and funds managed by BlackRock. Key partnership: exclusive license agreement with Sutro Biopharma for its cell-free protein synthesis platform.
- **Growth Signals**: 
  - Up to $1 billion commitment to expanding U.S. manufacturing with a new facility in North Carolina.
  - VAX-31 Phase 3 program (OPUS-1, OPUS-2, OPUS-3) topline data expected Q4 2026 – H1 2027.
  - Headcount growth: actively hiring across 100+ roles (Analytical, Commercial, Clinical, Conjugation, Quality, Regulatory).
  - Recognized as a Great Place to Work and Best Workplace in BioPharma (multiple years).

## Competitive Advantages
- **Broadest-spectrum PCV candidates**: VAX-31 is the broadest-spectrum pneumococcal conjugate vaccine in the clinic, targeting up to 31 serotypes.
- **Differentiated platform**: Cell-free protein synthesis allows for the creation of complex, high-fidelity vaccines that can overcome bacterial defense mechanisms (e.g., capsule-switching) that limit conventional cell-based vaccines.
- **Carrier-sparing technology**: Site-specific conjugation enables a higher valency (more serotypes) without compromising immunogenicity or tolerability.
- **Manufacturing scale**: Significant investment in U.S.-based production capacity provides a long-term supply chain advantage and aligns with "Investing in America" initiatives.

## Strategic Focus
- **Primary**: Advance VAX-31 and VAX-24 through late-stage clinical trials to secure regulatory approval and establish a new standard of care for pneumococcal disease.
- **Pipeline expansion**: Advance VAX-A1 (Group A Strep) and VAX-GI (Shigella) candidates through early clinical development.
- **Manufacturing**: Scale up internal manufacturing capabilities to support commercial launch and global supply.
- **Commercial readiness**: Building a commercial organization (e.g., hiring a VP of U.S. Market Access & Pricing, Senior Director of Product Launch) to prepare for potential VAX-31 launch.

## Why Work Here
- **Culture**: Described as a "kindness-first" mindset with a focus on audacious goals, collaboration, and mutual support. Recognized as a *Great Place to Work* and *Best Workplace in BioPharma* (Fortune).
- **Work Model**: Hybrid, Remote, and Onsite options available depending on role. San Carlos HQ offers a hybrid schedule.
- **Total Rewards**: 100% paid health, dental, and vision insurance; 401k matching; flexible PTO and holidays; paid parental and sick leave; equity awards (stock options & RSUs); Employee Stock Purchase Plan; lifestyle spending account; mental health and wellness resources.
- **Growth & Development**: Strong emphasis on learning culture, professional advancement through coaching, and career development programs.
- **Mission-driven**: Employees are directly contributing to creating vaccines that protect every child born and every adult at risk from bacterial infections globally.

## Sources
1. [vaxcyte.com](https://vaxcyte.com/)
2. [vaxcyte.com/careers](https://vaxcyte.com/careers/)
3. [vaxcyte.com/job-listings](https://vaxcyte.com/job-listings/)
4. [vaxcyte.com/culture](https://vaxcyte.com/culture/)
5. [vaxcyte.com/pipeline](https://vaxcyte.com/pipeline/)

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