Remote Senior Director, Quality Assurance & QC Oversight

Vaxcyte; San Carlos (CA); On-site; USD 229,000 - 268,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

Job summary

Vaxcyte, a clinical-stage vaccine company, is seeking a Senior Director of Quality Assurance in Raleigh, NC with global oversight responsibilities. The role ensures GMP compliance across analytical operations and coordinates with internal teams and external partners to support vaccines development and manufacturing programs.

The successful candidate will lead QA activities for method validation, release, and testing, and drive continuous improvement across multiple sites while managing vendor

Qualifications

• Bachelor’s degree in Biochemistry, Chemistry, or a related field; 15+ years of industry experience.
• Thorough knowledge of FDA, EU, ICH regulatory guidelines and pharmacopeia for method qualification and validation.
• Experience with biochemistry, immunoassay, or microbiological assays in QC environment.
• Excellent organizational and project management skills.
• Strong written and verbal communication; cross-functional collaboration.
• Experience in validation and transfer of analytical assays.
• Ability to lead and develop QA teams across multiple sites/countries.
• Knowledge of risk management principles.
• Experience with BLA submissions and commercial launch is desirable.

Responsibilities

• Provide QA oversight for method validation, release and in-process testing for Drug Substance and Polysaccharide.
• Liaise with QA and external partners to support analytical needs for relevant programs.
• Represent QA in cross-functional meetings.
• Review and approve GMP documentation including COAs, validation reports, deviations, change controls, risk assessments, and CAPAs.
• Partner with QC and contract labs to set KPIs for vendor performance.
• Drive resolution of quality issues with contract manufacturers and testing organizations.
• Review Quality Agreements and regulatory documentation.
• Lead quality investigations of testing deviations and OOS events.
• Contribute to regulatory filings and responses to health authorities.
• Participate in audit preparations and readiness.
• Develop and update GMP-related policies and procedures.
• Champion continuous GMP improvement across internal and external teams.

Skills

QA leadership

Regulatory compliance

GMP knowledge

Validation

Documentation

Project management

Cross-functional collaboration

Biochemistry knowledge

FDA/ICH familiarity

Vendor/CMO management

Education

Bachelor’s degree in Biochemistry, Chemistry, or related field

Tools

QMS software

CAPA system

Job description

Vaxcyte, a clinical-stage vaccine company, is seeking a Senior Director of Quality Assurance in Raleigh, NC with global oversight responsibilities. The role ensures GMP compliance across analytical operations and coordinates with internal teams and external partners to support vaccines development and manufacturing programs.

The successful candidate will lead QA activities for method validation, release, and testing, and drive continuous improvement across multiple sites while managing vendor