RemoteLeaf Logo
Log in Sign up

Sr. Director, Quality Assurance for Quality Control

1 hour, 42 minutes ago
United States
Full-time
Lead
QA Engineer
Quality Assurance and Testing
Apply Now
Vaxcyte

Vaxcyte

Vaxcyte is a vaccine innovation company developing high fidelity vaccines to eliminate bacterial infections globally, including the lead candidate VAX 24 for pneumococcal disease.

Pharmaceuticals
51-250
$984M raised
View All Jobs

Description

  • Lead quality oversight for method validation, release testing, and in-process testing for drug substance and polysaccharides.
  • Serve as the primary QA liaison with internal teams and external collaborators supporting analytical programs.
  • Represent QA in internal and external cross-functional team meetings.
  • Review and approve GMP documents, including specifications, Certificates of Analysis, validation reports, deviations, change controls, risk assessments, and CAPAs.
  • Evaluate reference standards, test methods, protocols, and raw data packages from contract manufacturers and contract testing laboratories.
  • Partner with QC, vendor management, and contract labs to define KPIs for vendor performance monitoring.
  • Drive resolution of quality performance issues with contract manufacturers and testing organizations.
  • Lead quality investigations for testing deviations and out-of-specification results.
  • Contribute to regulatory filings, respond to health authority questions, and support submission documentation quality.
  • Prepare for audits and help maintain ongoing inspection readiness.
  • Develop, review, and update GMP policies and procedures.
  • Promote quality excellence and continuous improvement by identifying systemic gaps and implementing sustainable solutions.

Requirements

  • Bachelor’s degree in Biochemistry, Chemistry, or a related field; other education and experience combinations may be considered.
  • 15+ years of relevant industry experience.
  • Thorough knowledge of FDA, EU, and ICH regulatory guidelines and pharmacopeia for biologics and vaccines.
  • Experience with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment.
  • Experience in validation and transfer of analytical assays.
  • Strong organizational and project management skills with the ability to manage multiple projects under tight timelines.
  • Excellent written and verbal communication skills and ability to work effectively in cross-functional teams.
  • Demonstrated ability to build and develop high-performing QA teams and influence cross-functional and executive stakeholders.
  • Knowledge and experience in risk management principles.
  • Knowledge of both clinical and commercial products is desired.
  • Ability to integrate and interpret interdisciplinary project information with a high-level understanding of the drug/vaccine development process.
  • Ability to work globally with CMOs across different countries and continents.
  • Experience managing geographically distributed QA teams across multiple sites or countries.
  • Experience in BLA submission and commercial launch is highly desirable.

Benefits

  • Competitive compensation package with comprehensive benefits.
  • Equity component included in the compensation package.
  • Salary range of $229,000 to $268,000 for North Carolina.
  • Remote work arrangement.
  • Equal opportunity employer consideration for all qualified applicants.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Carvana

Vehicle Inspector

Carvana 10K-50K Automotive

ADESA, a Carvana-owned auto auction company, is hiring a Vehicle Inspector to inspect, document, and report vehicle condition for customers at one of its U.S. locations.

United States Full-time Entry Level QA Engineer
$40k-$42k
1 hour, 27 minutes ago
Intetics

1094 | GIS Specialist

Intetics 1K-5K Internet Software & Services

Intetics Inc. is hiring a GIS Specialist to process LiDAR-based data for measuring and documenting pole heights and attachments within infrastructure projects.

Ukraine Full-time Entry Level QA Engineer
1 hour, 57 minutes ago
Ursa Major

Avionics Technician II

Ursa Major 251-1K Aerospace & Defense

Ursa Major is hiring an Avionics Technician to build, assemble, test, and support flight and test avionics hardware for propulsion and defense systems used in aerospace and national security missions.

United States Full-time Junior Embedded Systems Engineer QA Engineer
$69k-$89k
1 hour, 57 minutes ago
True Zero Technologies

Quality & Compliance Administrator PMO (R-00174)

True Zero Technologies 11-50 Internet Software & Services

True Zero Technologies is hiring a Quality & Compliance Administrator to support PMO growth by managing quality systems, compliance activities, and governance across government contracts and IDIQ vehicles.

Anywhere Full-time Mid Level Project Manager QA Engineer
Confluence JIRA Power BI
1 hour, 57 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers