Vaxcyte

Vaxcyte

Sr. Director, Quality Assurance for Quality Control

US - Remote · Director

Sponsorship not specified$229k-$268kDetected 14 days ago
Project ManagementVendor ManagementGMPFDA RegulatoryCommunicationCollaboration

About the role

  • Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
  • Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.
  • Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

Responsibilities

  • providing direct QA support to the analytical operations based in Switzerland, while also managing the San Carlos-based QA team responsible for oversight of smaller-scale analytical activities.
  • The Senior Director will work closely with internal teams (Process Development, MSAT, Quality Control, Regulatory, and Stability) and external partners (CDMOs and CTLs) to maintain the compliance of the analytical program.
  • Lead quality oversight activities related to method validation, release and in-process testing for Drug Substance and Polysaccharide
  • Serve as the primary liaison within Vaxcyte QA and with outside collaborators, building partnerships that support analytical needs for relevant programs.
  • Partner with QC, vendor management, and contract labs to set key performance indicators for monitoring vendor effectiveness.
  • Drive resolution of quality performance issues with contract manufacturers and testing organizations

Requirements

  • Bachelor's degree in Biochemistry, Chemistry, or a related field with 15+ years of relevant industry experience.
  • Experience working with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment.
  • Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines.
  • Excellent written and verbal communication skills, including the ability to work effectively in cross-functional teams.
  • Previous experience in validation and transfer of analytical assays.
  • Knowledge and experience in Risk Management principles.
  • Knowledge in both clinical and commercial product desired.
  • Ability to integrate and interpret interdisciplinary project information
  • Ability to work globally with CMOs in different countries and continents.
  • Experience in BLA submission and commercial launch is highly desirable

Compensation

  • $229,000 - $268,000 (North Carolina)
  • The compensation package will be competitive and includes comprehensive benefits and an equity component.

Company info

  • Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote
  • Join our Mission to Protect Humankind!

Equal opportunity

  • We are an equal opportunity employer.
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This listing is sourced directly from Vaxcyte's careers page and normalized into a canonical job model.