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 highly skilled Senior Manager, Quality Systems to ensure adherence to regulatory standards, continuous improvement, and operational excellence within our organization. The ideal candidate will have experience with GxP system implementation and validation, a strong background in regulatory requirements, and a proven track record of successfully implementing and maintaining quality systems in a regulated industry.
Essential Functions:
- Assist with implementation and validation of the company's ERP (Enterprise Resource Planning) system in accordance with company procedures and regulatory requirements (e.g.,.21CFR Part 11).
- Support continuous improvement initiatives that relate to GxP System Validation to enhance quality, efficiency, and compliance across all departments.
- Represent Quality on cross-functional and project teams to assure systems are implemented in compliance with applicable regulations and guidelines.
- Work closely with IT, ITQA and system Business Owners to support the deployment, implementation and updates to computerized systems.
- Collaborate cross-functionally with IT, Quality Control, Regulatory Affairs, and other departments to ensure alignment on quality objectives and initiatives.
- Monitor key quality metrics, analyze trends, and assist to implement measures to improve performance and mitigate risks.
- Strive to foster a culture of quality and continuous improvement.
- Prepare for and participate in regulatory inspections and customer audits, ensuring readiness and compliance.
- Complete other responsibilities, as appropriate.
· Ensure alignment with department management and company vision.
· Promote a quality mindset and quality excellence approach to all activities.
Requirements:
- Bachelor's degree in a relevant scientific or engineering discipline.
- Minimum of 9+ years of experience in quality management within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology).
- Demonstrate knowledge of GXP regulations and guidelines as it pertains to Quality Systems.
- Proven experience in implementing and managing GxP systems, 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 ERP implementation and validation required.
- Knowledge and 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: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $176,000 – $190,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
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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What We Do
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte’s lead candidate, VAX-24, is a 24-valent, broad-spectrum pneumococcal conjugate vaccine being developed for the prevention of invasive pneumococcal disease. Vaxcyte is re-engineering the way highly complex immunizations are made through modern synthetic techniques, including advanced chemistry and the XpressCFᵀᴹ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of greater than 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked.
