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Director, Document Control

Employer
Vaxcyte, Inc.
Location
San Carlos, California
Start date
Mar 28, 2023

View more

Discipline
Regulatory, Research/Documentation
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

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 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 an expanded breadth of coverage of greater than 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. 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.
 
Summary:
 
Vaxcyte is looking for an energetic and talented individual to join Vaxcyte’s Vaccine Product Development organization as a Director within the Quality Control Unit. The primary function of this level position is to lead the stability program for all products in preclinical and clinical development. This position reports directly to the Director of Quality Control. 
Essential Functions:
    • Responsible for the ownership and management of the document control system.
    • Ensure accurate and reliable filing systems for all electronic and paper-based GxP documents.
    • Lead and mentor the document control team.
    • Ensure the training program is effectively administered.
    • Define the policies/procedures for document control processes and training programs.
    • Collaborate with all levels of leaders to resolve document management and training issues.
    • Oversee the routine document control and training operations, including ensuring appropriate document standards are developed and managed, workflows are processed, all documents archived appropriately, training requirements are identified and completed, and new hires are effectively onboarded.
    • Develop and implement plans to ensure current and future processes and systems meet users requirements.
    • Maintain EDMS compliant to applicable regulatory requirements.
    • Assist and support audits as a subject matter expert for Document Control.

Requirements:
    • BA or BS, with 10 years of industry experience in Pharma / Biotech industry.
    • Experience with managing key Quality Management System.  
    • Hands on experience with utilizing EDMS.
    • Experience with Veeva is preferred.
    • Strong understanding of documents and records associated with GxP manufacturing and testing activities.
    • Understanding of current regulatory expectation including 21 CFR Part 11 requirements.
    • Strong professional interpersonal and communication skills, both verbal and written, to provide clear direction for the business, vendors, and internal stakeholders.
    • Demonstrated ability to collaborate and influence cross organization to gain support and commitment for team goals.
    • Experience building document management and training programs.
    • 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: $212,000 - $225,000
 
 

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.

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

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