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Sr. Director/ Vice President, Quality Assurance

Employer
Vaxcyte, Inc.
Location
San Carlos, California
Start date
Nov 6, 2022

View more

Discipline
Quality, Quality Assurance, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

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 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-XP, a PCV with coverage of 31 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease. 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 150 employees and anticipates continued, significant growth. Following the October 2022 follow-on equity offering, which generated approximately $651 million in net proceeds, the Company’s balance sheet is further strengthened to advance its pipeline of novel vaccines, including VAX-24. On October 24, 2022, the Company announced positive topline safety, tolerability and immunogenicity data from the Phase 1/2 proof-of-concept study evaluating VAX-24 in adults aged 18-64. 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-XP, 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:
    • Collaborate with senior leadership to provide strategic and technical leadership of Quality Assurance activities and outcomes. You'll lead a culture of Quality by conceiving, collaborating, and supporting the implementation of specific actions, processes, and behaviors.
    • Help to implement, monitor, and promote good practice of all Quality Assurance Systems to ensure compliance with relevant FDA, EMA/other OUS regulations/directives/requirements and ICH guidelines.
    • Establish required phase-appropriate GxP systems.
    • Evolve, audit, and monitor Standard Operating Procedures (SOPs) to ensure they are in accordance with GxP guideline. Carry out corrective actions for identified deviations.
    • Establish and oversee appropriate GXP tracking systems.
    • Oversight of contract service providers from a quality compliance perspective including monitoring CSP performance.
    • Lead executive management reviews.
    • Be responsible for CQA validation and audit of computer systems in support of development, operations, and pharmacovigilance.
    • Partners with functional areas in study design, data collection, and analysis, and reporting activities that support quality improvement interventions, transparency, compliance with regulatory standards, and provide performance monitoring.
    • In coordination with peers, develop and implement a common platform of quality and compliance systems, tools, procedures, and standards.
    • Work to develop a quality CMC strategy via objectives and plans to ensure quality oversight, timely resolution of issues, and early intervention to assure compliance.
    • Review Quality Agreements, Validation Master Plans and protocols for CMOs to implement in order to ensure requirements for CTA and BLA filings are met.
    • Direct and mentor a team of dedicated and exceptional Quality Assurance professionals.
    • Accountable for training and education on GxPs and SOPs.
    • Accountable for the preparation and conduct of all inspections by any regulatory authority.

Requirements:
    • Minimum 15 years of experience in the biotechnology industry and at least 7 years in a Quality leadership role.
    • Bachelor's degree in a scientific field or relatable field required; Master's or Ph.D. a plus.
    • Track record of establishing Quality systems in a phase-appropriate manner.
    • Proven success with establishing a strong Clinical QA team.
    • Experience with cGMP requirements and with US and International regulatory authority inspection requirements and first-hand experience hosting pre-approval inspections.
    • Success in collaborating on IND, BLA/NDA, and MAA submissions for novel products.
    • All Vaxcyte employees require vaccination against COVID-19.

Reports to: Senior Vice President of Regulatory Affairs
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 

Company

Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease.

Find Us
Website
Phone
(650) 837-0111
Location
825 Industrial Road, Suite 300
San Carlos
CA
94070
US
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