Manager, Quality Systems

Vaxcyte•San Carlos, CA

8h•$148,000 - $173,000•Hybrid

About The Position

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.

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.
Ability to work in a collaborative team environment.

Nice To Haves

Knowledge or experience with Computer System Validation and/or Computer Software Assurance highly desirable.
Experience with test script execution, a plus.

Responsibilities

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.