Document Control Specialist

Company Profile

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. 

Summary
Vaxcyte is looking for a talented Document Control Specialist, who will be responsible for
the oversight of the GxP QMS processes. This includes, but is not limited to, Document Management and Training. The role is focused on maintaining the Quality Systems associated with the manufacturing and testing of our vaccines and preparing for future clinical trials.
Essential Functions

• Maintenance of the Quality Systems documentation in Veeva (electronic document control system) and other electronic systems where required
• Perform the QA document control function in QA and Regulatory Affairs, including managing document workflows in Veeva, tracking, processing, approval, distributing, and archiving documents/records with overall responsibility for document control processes.
• Work closely with external vendors, functional areas and Project Management team for daily management of routing, revisions, approval, and filing of documents within defined timelines
• Organize and ensure accurate and reliable filing systems for all electronic and paper-based GMP documents
• Maintain in-house training programs, including training matrix, training files, and audits of training files
• All Vaxcyte employees require vaccination against COVID-19. 

Requirements

• Bachelor's BA/BS degree or equivalent experience
• Four (4) to six (6) plus-years of biopharmaceutical industry experience
• Experience with managing key Quality Management System processes (e.g., Document Control, Change Management, Training)
• 2-4 years of experience with document management utilizing EDMS systems. Experience with Veeva QualityDocs and Veeva RIM preferred.
• Familiarity with documents and records associated with GxP manufacturing and testing activities
• Understanding of current regulatory expectations including 21CFR Part 11 requirements
• Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
• Strong professional interpersonal and communications skills, both verbal and written, to provide clear direction for the business, vendors, and internal stakeholders
• Strong attention to detail, organizational skills, ability to work in a faced paced environment
• Ability to meet deadlines and multi-task efficiently
• Proficient with the SmartSheet, Microsoft Office Suite, Word, Excel, PowerPoint and Project

Reports to: Vice President of Regulatory Affairs

Location: Foster City, CA

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

Vaxcyte, Inc.
353 Hatch Drive
Foster City, CA 94404