Associate Director, Quality Systems

Company Profile:

Vaxcyte, Inc. (Nasdaq: PCVX) is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease (IPD). The Company is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and our exclusively licensed XpressCFTM cell-free protein synthesis platform. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-31, a 31-valent PCV candidate; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. The Company is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.

Vaxcyte, headquartered in San Carlos, CA, went public in June 2020 and currently has a team of approximately 180 employees and anticipates continued, significant growth. Following equity offerings in October 2022 and April 2023, which generated over $1.1 billion in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. These financings followed positive data readouts from Vaxcyte’s Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64 and Phase 2 study in adults 65 and older. The Company believes these results support a best-in-class potential for VAX-24, which was designed to replace the current standard-of-care in adults and children. VAX-24 is being investigated for the prevention of IPD, which can be most serious for infants, young children, older adults and those with immune deficiencies or certain chronic health conditions. Given the global impact of pneumococcal disease remains significant, the public health community continues to advocate for vaccines that can offer broader protection to prevent IPD. Vaxcyte’s PCV franchise, consisting of VAX-24 and VAX-31, is designed specifically to address this need and has the potential to deliver the broadest protection for this very serious disease. We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.

• Represent Quality on cross-functional and project teams to assure systems are implemented in compliance with applicable regulations and guidelines.
• Own the workflow for quality systems deviations, CAPA, and change controls.
• In collaboration with stakeholders, support the deployment, implementation and updates to computerized systems.
• Review and approve validation protocols and reports for system validations.
• Execute documentation for qualification and validation activities to support computer system validation projects.
• Assist with the development and implementation of SOPs, Work Instructions and policies.
• Identify, evaluate and drive continuous improvement opportunities.
• Maintain knowledge of current regulatory changes and industry trends and apply to Vaxcyte procedures.
• Collaborate with key stakeholder to develop solutions to complex issues.
• Ensure alignment with department management and company vision.
• Promote a quality mindset and quality excellence approach to all activities.
• Complete other responsibilities, as appropriate.

• BS or BA with 10 years relevant industry experience.
• Demonstrate knowledge of GXP regulations and guidelines as it pertains to Quality Systems.
• Strong Management and process improvement skills.
• Demonstrate excellent verbal, written, and interpersonal communication skills.
• Demonstrate experience leading and contributing through influence and working in cross functional teams.
• System implementation experience.
• Well organized and capable of managing multiple projects.
• Experience writing, reviewing and editing Policies, SOPs, and WI.
• Ability to work in a collaborative team environment.
• All Vaxcyte employees require vaccination against COVID-19.

Reports to: Executive Director, Quality Assurance

Location: San Carlos, CA

Compensation:

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

Salary Range: $192,000 – $199,000

Send resumes to:

careers@vaxcyte.com

Vaxcyte, Inc.

825 Industrial Road, Suite 300

San Carlos, CA 94070

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.