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:
Vaxcyte is seeking a Manager, QMS Vendor Management & Supplier Notifications to support the effective management of supplier-related quality activities within the Quality Management System (QMS). This role will be responsible for the intake, triage, and coordination of supplier notifications within Veeva QMS, ensuring timely impact assessments and appropriate follow-up actions. The individual will partner cross-functionally to assess risk, drive change controls, and maintain supplier compliance. This role will also contribute to vendor qualification activities, supplier management processes, and may support internal and external audit activities as needed.
Essential Functions:
- Supplier Notification Management
- Manage the end-to-end lifecycle of supplier notifications within Veeva QMS, including intake, triage, prioritization, and tracking.
- Perform initial assessments of supplier notifications to determine required actions and level of impact.
- Assign and coordinate impact assessments with cross-functional stakeholders (e.g., Quality, Regulatory, Manufacturing, Supply Chain).
- Ensure timely closure of supplier notifications in alignment with internal procedures and regulatory expectations.
- Maintain visibility of notification status, risks, and trends, escalating issues as appropriate.
- Impact Assessments & Action Management
- Facilitate and track impact assessments to evaluate potential effects on product quality, regulatory filings, and supply continuity.
- Coordinate and manage follow-up actions, including change controls, supplier communications, and documentation updates.
- Ensure actions are completed in a timely manner and in compliance with QMS requirements.
- Support risk-based decision making and documentation aligned with GxP expectations.
- Vendor Management & Qualification
- Support vendor qualification and requalification activities, including risk assessments and documentation review.
- Maintain supplier records and ensure compliance with approved supplier lists and quality agreements.
- Partner with cross-functional teams to ensure suppliers meet Vaxcyte quality and compliance standards.
- Assist in maintaining supplier performance metrics and supporting supplier oversight activities.
- Audit Support
- Participate in internal and external audits, including supplier audits, as needed.
- Support audit preparation activities and contribute to responses and CAPA development for audit observations.
- Assist in tracking and closure of audit-related actions.
Requirements:
- BA or BS in a scientific or related field.
- Minimum of 5 years of experience in Quality Assurance, Supplier Quality, or Vendor Management within the biopharmaceutical, vaccine, or regulated industry. Other combinations of education and/or experience may be considered.
- Experience working within a Quality Management System (QMS), preferably Veeva QMS.
- Strong understanding of GxP regulations (GMP, GLP, GCP) and supplier quality requirements.
- Experience with supplier notifications, change control, and impact assessments preferred.
- Familiarity with vendor qualification and audit processes.
- Strong organizational and project management skills with the ability to manage multiple priorities.
- Excellent communication and cross-functional collaboration skills.
- Detail-oriented with strong problem-solving and risk assessment capabilities.
- ASQ certification (CQA, CQE) or auditor certification preferred.
Reports to: Senior Director, Global Quality Management Systems and Compliance
Location: Hybrid; San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $142,000 – $165,000 (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.