Vaxcyte
Overview
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Manager, Quality Systems (contract)
role at
Vaxcyte . We are a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. Our work focuses on addressing infections such as invasive pneumococcal disease, Group A Strep, and Shigella, with a commitment to clear, well-defined goals and durable execution. We are seeking a highly skilled professional to ensure adherence to regulatory standards, drive continuous improvement, and support operational excellence within our organization. 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). Assist with driving continuous improvement initiatives related to QMS to enhance quality, efficiency, and compliance across all departments. Collaborate cross-functionally with IT and other departments to align quality objectives and initiatives. Foster a culture of quality and continuous improvement. Assist with preparation for and participation in regulatory inspections and customer audits, ensuring readiness and compliance. Ensure alignment with department management and the company vision. Promote a quality mindset and a quality excellence approach across 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). Demonstrated knowledge of GXP regulations and guidelines as they pertain to Quality Systems. Experience assisting with the validation, implementation, and management of QMS compliant with FDA regulations (e.g., 21 CFR Part 820) and other relevant requirements. Experience driving cross-functional collaboration. Excellent analytical and problem-solving abilities with strong attention to detail. Experience with Veeva QMS is required. Knowledge or experience with Computer System Validation and/or Computer Software Assurance is highly desirable. Experience with test script execution is a plus. Ability to work in a collaborative team environment. Job Details
Reports to:
Associate Director, Quality Systems Location:
Hybrid; San Carlos, CA Expected Contract Length:
6-7 months Hourly Range:
$70.00 - $78.00 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.
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Join to apply for the
Manager, Quality Systems (contract)
role at
Vaxcyte . We are a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. Our work focuses on addressing infections such as invasive pneumococcal disease, Group A Strep, and Shigella, with a commitment to clear, well-defined goals and durable execution. We are seeking a highly skilled professional to ensure adherence to regulatory standards, drive continuous improvement, and support operational excellence within our organization. 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). Assist with driving continuous improvement initiatives related to QMS to enhance quality, efficiency, and compliance across all departments. Collaborate cross-functionally with IT and other departments to align quality objectives and initiatives. Foster a culture of quality and continuous improvement. Assist with preparation for and participation in regulatory inspections and customer audits, ensuring readiness and compliance. Ensure alignment with department management and the company vision. Promote a quality mindset and a quality excellence approach across 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). Demonstrated knowledge of GXP regulations and guidelines as they pertain to Quality Systems. Experience assisting with the validation, implementation, and management of QMS compliant with FDA regulations (e.g., 21 CFR Part 820) and other relevant requirements. Experience driving cross-functional collaboration. Excellent analytical and problem-solving abilities with strong attention to detail. Experience with Veeva QMS is required. Knowledge or experience with Computer System Validation and/or Computer Software Assurance is highly desirable. Experience with test script execution is a plus. Ability to work in a collaborative team environment. Job Details
Reports to:
Associate Director, Quality Systems Location:
Hybrid; San Carlos, CA Expected Contract Length:
6-7 months Hourly Range:
$70.00 - $78.00 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.
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