Senior Manager, Clinical QA - Hybrid/Remote

Vaxcyte; San Carlos (CA); Hybrid; USD 163,000 - 191,000; Full time

Job summary

Vaxcyte in San Carlos, CA, is seeking a Senior Manager, Clinical Quality Assurance to lead global investigations, CAPA development, and QA activities across clinical development to ensure GCP compliance and high-quality healthcare solutions.

The role requires nine years in QA within the clinical/pharma space, knowledge of QMS (Veeva preferred), and strong collaboration with cross-functional teams, with up to 15% travel and hybrid onsite/remote work.

Qualifications

• BA or BS in related field.
• Minimum of 9 years of experience in Quality Assurance within the clinical or pharmaceutical industry.
• Knowledge of QMS systems (Veeva preferred).
• GCP QA Certification preferred (RQAP-GCP or similar).
• Experience across all phases of clinical development.
• Knowledge of 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%.

Responsibilities

• Lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, SOPs and project-specific guidelines.
• Manage Quality Issues and serious breach investigations.
• Review, approve Investigations, RCA, CAPA and Effectiveness Check plans.
• Track until closure quality events from Quality Issues, Audits, Inspections or other QA activities.
• Manage/oversee quality event updates in eQMS.
• Plan, schedule, and conduct risk-based and For Cause audits of clinical investigators sites, CROs, and other GCP vendors.
• Support regulatory agency inspection readiness activities, including mock inspections, gap assessments, and inspection response coordination.
• Evaluate policies and procedures for compliance and provide recommendations for continuous process improvements.
• Support QA initiatives/projects for quality and process improvements.
• Promote a quality mindset and quality excellence across activities.
• Understand and interpret regulatory agency policies and guidance for GCP and implement compliant processes at Vaxcyte.

Skills

Quality Assurance

CAPA Management

Root Cause Analysis

GCP Knowledge

FDA Regulations

Veeva

QA Tools

Communication Skills

Analytical Thinking

Travel 15%

Education

BA/BS in related field

Tools

Veeva QMS

Job description

Vaxcyte in San Carlos, CA, is seeking a Senior Manager, Clinical Quality Assurance to lead global investigations, CAPA development, and QA activities across clinical development to ensure GCP compliance and high-quality healthcare solutions.

The role requires nine years in QA within the clinical/pharma space, knowledge of QMS (Veeva preferred), and strong collaboration with cross-functional teams, with up to 15% travel and hybrid onsite/remote work.