Senior Manager, Clinical QA – Hybrid/Remote

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

Job summary

Vaxcyte is seeking a dedicated and experienced Senior Manager, Clinical Quality Assurance, to join our dynamic team. The ideal candidate will have a strong background in quality management within a clinical setting and a passion for maintaining the highest standards of clinical excellence.

This role requires an individual who can work with teams to ensure compliance with regulatory requirements and achieve our mission of delivering high-quality healthcare solutions.

Qualifications

• BA or BS in a related field and 9+ years in QA within clinical/pharma.
• Strong knowledge of FDA regulations and ICH guidelines.
• Experience with QMS systems (Veeva preferred) and QA tools.
• Excellent communication and cross-functional collaboration.
• Willingness to travel up to 15%.

Responsibilities

• Lead global investigations and CAPA plans per SOPs and guidelines.
• Manage quality issues and serious breach investigations.
• Review and approve RCA, CAPA, and EC plans.
• Track quality events from audits and QA activities.
• Plan and conduct risk-based audits of clinical sites and CROs.
• Support regulatory inspections and readiness activities.
• Promote a quality mindset across the organization.

Skills

Communication

Analytical thinking

Problem solving

Collaboration

Education

Bachelor's degree in related field

GCP QA Certification

Tools

Veeva

Job description

Vaxcyte is seeking a dedicated and experienced Senior Manager, Clinical Quality Assurance, to join our dynamic team. The ideal candidate will have a strong background in quality management within a clinical setting and a passion for maintaining the highest standards of clinical excellence.

This role requires an individual who can work with teams to ensure compliance with regulatory requirements and achieve our mission of delivering high-quality healthcare solutions.