Director, Quality Assurance, Drug Product

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.

Essential Functions:

• Responsible for overall quality management of Drug Product manufacturing activities.
• Perform master batch record and executed batch record review.
• Represent QA at internal and external cross functional team meetings.
• Review and approve internal and external documentation for compliance such as validation protocols and reports, deviations, risk assessments, change controls, and CAPAs.
• Lead lot disposition activities for DP and labelled DP.
• Perform quality management oversight of DP and Packaging contract service providers.
• Assess changes control records to ensure changes are executed in a controlled and compliant matter.
• Drive resolution of quality performance issues with contract manufacturers.
• Lead quality investigation of deviations.
• Identify and implement corrective and preventative actions.
• Establish, review, and periodically update GMP related internal procedures and policies.
• Support process improvement initiatives.
• Provide QA oversight and evaluation for risk assessments, as required.
• Collaborate with internal key stakeholders to resolve quality matters.
• Maintain appropriate development phase GMP compliance for product manufacture.
• Lead or assist in compliance audits as required.
• Support health authority inspections as needed.
• Review Quality Agreements
• Promote a quality mindset and quality excellence approach to all activities.

Requirements:

• BS or BA with 12 years relevant industry experience.
• Demonstrate in-depth knowledge of GMPs, FDA regulations and ICH guidelines.
• Knowledge and experience in Risk Management principles
• Management experience desired.
• Knowledge in both clinical and commercial produ