Manager, Quality Systems

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.

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 highly skilled Manager, Quality Systems to ensure adherence to regulatory standards, continuous improvement, and operational excellence within our organization. The ideal candidate will have experience in quality management systems (QMS), a background in regulatory requirements, and experience successfully validating, implementing and maintaining quality systems in a regulated industry.

Essential Functions:

• Assist with development and maintenance of the company's Quality Management System (QMS) in accordance with company procedures and regulatory requirements (e.g.,.21CFR Part 11).

• Act as SME for the Vaxcyte QMS and assist users with technical system issues.

• Assist with driving continuous improvement initiatives that relate to QMS to enhance quality, efficiency, and compliance across all departments.

• Assist with GxP system implementation, validation, and maintenance activities from a QA perspective as required.

• Collaborate cross-functionally with IT, and other departments to ensure alignment on quality objectives and initiatives.

• Strive to foster a culture of quality and continuous improvement.

• Assist with preparation for and participate in regulatory inspections and customer audits, ensuring readiness and compliance.

• Ensure alignment with department management and company vision.

• Promote a quality mindset and quality excellence approach to all activities.

• Complete other responsibilities, as appropriate.

Requirements:

• Bachelor's degree in a relevant scientific discipline.

• Minimum of 5 years of experience in quality management within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology). Other combinations of education and/or experience may be considered.

• Demonstrate knowledge of GXP regulations and guidelines as it pertains to Quality Systems.

• Experience in assisting with the validation, implementation, and managing Quality Management Systems (QMS) compliant with FDA regulations (e.g., 21 CFR Part 820), and other relevant regulatory requirements.

• Experience driving cross-functional collaboration.

• Excellent analytical and problem-solving abilities, with a keen attention to detail.

• Experience with Veeva QMS required.

• Knowledge or experience with Computer System Validation and/or Computer Software Assurance highly desirable.

• Experience with test script execution, a plus.

• Ability to work in a collaborative team environment.

Reports to: Associate Director, Quality Systems

Location: Hybrid; San Carlos, CA

Compensation:

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

Salary Range: $148,000 - $173,000 (SF Bay Area). Salary ranges for non-California locations may vary.
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.