Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to safeguard humankind against the consequences of bacterial diseases. These diseases have severe and costly health repercussions when left unchecked.

We are working towards eradicating or treating bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella. Our path to success is clear and well-defined.

Our Core Values:

1. Rethinking Conventions: We bring creative and intellectual diversity to every aspect of our work to innovate and re-innovate the way vaccines are delivered.
2. Aiming High: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
3. Leading with Heart: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
4. Modeling Excellence: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Job Title: Associate Director, Clinical Quality Assurance

We are seeking a dedicated and experienced Associate Director, 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.

Key Responsibilities:

1. Lead quality oversight of Adult Phase III Vaccine Program.
2. Provide guidance to Clinical Operations team on multiple Phase III trials.
3. Manage a team of 1-4 QA employees dedicated to the Adult Vaccine Program.
4. Identify potential risks associated with study design/execution and collaborate with subject matter experts to implement mitigation strategies to minimize quality issues.
5. Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
6. Provide Clinical Quality Assurance updates to Clinical Operations, and Clinical Operations updates to upper QA Management.
7. Support Inspection Readiness activities for Vaxcyte, Clinical Sites and Clinical Service Providers.
8. Support QA initiatives/projects for quality, process improvements.
9. Promote a quality mindset and quality excellence approach to all activities.
10. Understand and interpret regulatory agencies' policies and guidance as it pertains to GCP requirements and assist in the implementation of compliant processes at Vaxcyte.

Requirements:

1. BA or BS in related field.
2. Minimum of 10 years of experience in Quality Assurance within the clinical or pharmaceutical industry.
3. Experience in oversight of Phase III vaccine trials.
4. Demonstrate in-depth knowledge of GCPs, FDA and EU requirements and ICH guidelines.
5. Experience across all phases of clinical development.
6. Strong project management skills with the ability to manage multiple projects simultaneously.
7. Demonstrate ability to oversee assigned QA team.
8. GCP QA Certification preferred (RQAP-GCP, or similar).
9. Proficiency in QA tools and software (Veeva preferred).
10. Excellent communication and interpersonal skills, with the ability to work collaboratively with diverse teams.
11. Strong analytical and problem-solving skills, with a keen attention to detail.
12. Strong sense of ownership in areas of responsibility.

About Us:

Vaxcyte is a clinical-stage vaccine innovation company committed to protecting humankind from bacterial diseases. We are driven by a passion for innovation and a dedication to delivering high-quality healthcare solutions.

At Vaxcyte, we value diversity, inclusion, and collaboration. We strive to create a work environment that fosters creativity, intellectual curiosity, and a passion for improving human health.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates regardless of their background or experiences.