Sr. Manager, Clinical Quality Assurance

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, periodontitis 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:

• Provide GCP compliance oversight and support to the clinical program and clinical study team.
• Collaborate with cross-functional teams to address quality issues and implement corrective actions.
• Contributes to the development, maintenance, and implementation of GCP-related policies and SOPs.
• Conduct and support GCP audits of clinical vendors and investigator sites, as applicable.
• Support inspection readiness activities and make recommendations for continuous improvements.
• Assists in constructing annual GCP trainings.
• 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.
• GCP QA Certification preferred (RQAP-GCP, or similar).
• Minimum of 7 years of experience in Quality Assurance within the clinical or pharmaceutical industry, or within Clinical Operations.
• 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.

Reports to: Director, Clinical Quality Assurance
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $179,000 – $190,000