Senior Manager, Clinical Quality Assurance

Vaxcyte

. Lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, SOPs and project-specific guidelines/instructions.

Posted 9/15/2026full-timeSan Carlos • California • United StatesSenior💰 $163,000 - $191,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Quality Assurance within the clinical or pharmaceutical industry, with a strong focus on regulatory compliance, CAPA preparation, and risk-based auditing. Proficient in managing quality events and promoting a quality mindset across teams.

Highest-signal resume keywords

Quality Assurance ManagementGCP QA CertificationRoot Cause AnalysisRegulatory ComplianceQMS System Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CAPA PreparationRoot Cause AnalysisRisk-Based AuditingQuality Event TrackingRegulatory Compliance EvaluationClinical Development Phases KnowledgeFDA Regulations KnowledgeICH Guidelines Knowledge

Soft Skills

Excellent Communication SkillsInterpersonal SkillsAnalytical SkillsProblem-Solving SkillsAttention to Detail

Tools & Technologies

EQMSVeeva

Certifications & Qualifications

GCP QA CertificationRQAP-GCP

Industry Keywords

Clinical Quality AssuranceQuality Management SystemRegulatory Agency Inspection ReadinessContinuous Process ImprovementQuality Excellence

About the role

Key responsibilities & impact

Lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, SOPs and project-specific guidelines/instructions.
Manage Quality Issues and serious breach investigations.
Review and approve Investigations, Root Cause Analysis, CAPA and Effectiveness Check plans.
Track quality events from Quality Issues, Audits, Inspections and similar QA activities until closure.
Manage and oversee quality event updates in eQMS.
Plan, schedule and conduct risk-based and For Cause audits of clinical investigator sites, CROs and other GCP vendors.
Support regulatory agency inspection readiness, including mock inspections, gap assessments and inspection response coordination.
Evaluate policies and procedures for regulatory compliance and recommend continuous process improvements.
Support QA initiatives and process improvement projects.
Promote a quality mindset and quality excellence across activities.
Interpret regulatory agency policies and guidance related to GCP requirements and assist with implementing compliant processes at Vaxcyte.
Report to the Senior Director, Clinical Quality Assurance.

Requirements

What you’ll need

BA or BS in related field.
Minimum of 9 years of experience in Quality Assurance within the clinical or pharmaceutical industry. Other combinations of education and/or experience may be considered.
Knowledge of QMS system (Veeva preferred).
GCP QA Certification preferred (RQAP-GCP, or similar).
Experience across all phases of clinical development.
Knowledge of applicable FDA regulations and ICH guidelines.
Proficiency in QA tools and software (Veeva preferred).
Excellent communication and interpersonal skills, with the ability to work collaboratively with diverse teams.
Strong analytical and problem-solving skills, with a keen attention to detail.
Ability to travel up to 15%.

Benefits

Comp & perks

Comprehensive benefits
Equity component