Senior Manager, Clinical Quality Assurance

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

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT We Do Is Every Bit As Important As HOW We Do It! Our Work Together Is Guided By Four Enduring Core Values

• RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
• LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary

We are 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.

Essential Functions

• Lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures (SOPs) and project specific guidelines/instructions.
• Manage Quality Issues and serious breach investigations.
• Review, approve Investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans.
• Track until closure quality events from Quality Issues, Audits, Inspections or during similar QA activities.
• Manage/oversee quality event update 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 with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• Support in QA initiatives/projects for quality, process improvements.
• Promotes a quality mindset and quality excellence approach to all activities.
• Understands and interprets regulatory agencies policies and guidance as it pertains to GCP requirements and assists in the implementation of compliant processes at Vaxcyte.

Requirements

• 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%.

Reports to: Senior Director, Clinical Quality Assurance

Location: San Carlos, CA; Open to Remote

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Hybrid (minimum of 3 days per week onsite) / Remote

Compensation

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range

$163,000 – $191,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Equal Opportunity

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.