Supplier Quality Manager

Neurona Therapeutics•South San Francisco, CA

1d•$140,000 - $150,000•Onsite

About The Position

Neurona Therapeutics is seeking a Supplier Quality Manager to develop, implement, execute, and continuously improve the company’s Supplier Quality Management program. Reporting to the Director, QA Systems, this role provides Quality oversight of GxP suppliers, vendors, service providers, contract organizations, and other external partners that support development and manufacture of Neurona’s cell therapy products. The Supplier Quality Manager is the Quality Systems subject matter expert for supplier qualification, risk assessment, audits, Quality Agreements, ongoing performance monitoring, Supplier Corrective Action Requests (SCARs), and periodic requalification. The position partners with Quality, Manufacturing, Supply Chain, Technical Operations, CMC, Clinical, Information Technology, and other functions to ensure externally provided materials and services meet company requirements and regulatory expectations. This role combines program ownership with hands-on execution and is responsible for building a scalable, risk-based supplier quality program suited to a growing clinical-stage cell therapy organization. The position is on-site in South San Francisco, California.

Requirements

Bachelor’s degree in Life Sciences, Engineering, Quality, Biotechnology, or a related scientific or technical discipline.
Approximately 7 or more years of progressively responsible experience in Quality Assurance, Supplier Quality, Quality Systems, Manufacturing Quality, or a related GxP function within biotechnology, pharmaceutical, cell or gene therapy, medical device, or another regulated life-sciences environment.
At least 3 years of direct supplier or vendor quality management experience, including supplier qualification, audits, Quality Agreements, and/or supplier performance management.
Demonstrated knowledge of GMP/GxP quality systems and supplier oversight requirements.
Experience conducting or supporting supplier audits and managing audit observations through closure.
Experience reviewing investigations, root cause analyses, CAPAs, and supplier corrective actions.
Strong working knowledge of supplier quality management and risk-based supplier oversight.
Knowledge of applicable FDA regulations and guidance, ICH quality principles, and current Good Manufacturing Practices.
Strong understanding of deviation, investigation, root cause analysis, CAPA, change control, audit, and Quality Management Review processes.
Ability to assess supplier risk and translate complex quality information into clear recommendations for management.
Strong technical writing and report-writing skills.
Ability to manage supplier escalations professionally and effectively.
Strong analytical skills and experience developing meaningful supplier quality metrics and trends.
Ability to work independently while effectively influencing cross-functional teams.
Strong organizational and project-management skills, including the ability to manage multiple suppliers, audits, Quality Agreements, and deliverables concurrently.
Ability to develop pragmatic solutions for a growing biotechnology organization while maintaining appropriate GxP compliance.
Excellent written and verbal communication skills and a strong commitment to data integrity and documentation excellence.

Nice To Haves

Experience in cell therapy, gene therapy, biologics, or other advanced therapeutic products.
Experience supporting a clinical-stage organization progressing toward commercial readiness.
Experience with electronic Quality Management Systems; Qualio experience is a plus.
Experience qualifying GxP computerized systems, SaaS providers, laboratories, CMOs/CDMOs, material suppliers, consultants, and other regulated service providers.

Responsibilities

Own and administer the GxP supplier and vendor qualification program in accordance with company procedures and regulatory requirements.
Lead risk-based assessment, qualification, approval, monitoring, requalification, and disqualification of suppliers.
Review and approve supplier qualification questionnaires and supporting documentation; assess supplier quality systems, technical capabilities, compliance history, and risks to product quality, patient safety, data integrity, and regulatory compliance.
Establish qualification requirements based on supplier type, criticality, intended use, and GxP risk, and maintain complete, traceable, inspection-ready qualification decisions and records in the electronic Quality Management System, including the Approved Vendor List.
Support development and maintenance of a risk-based supplier audit program and schedule; plan, conduct, and document on-site, remote, and qualification audits of GxP suppliers and service providers.
Support regulatory inspections and partner audits involving supplier oversight.
Lead preparation, review, negotiation, approval, maintenance, and periodic review of GxP Quality Agreements; ensure responsibilities are defined for quality matters such as deviations, investigations, CAPAs, change notification, complaints, data integrity, records, audits, subcontracting, and inspections.
Partner with Legal, Supply Chain, CMC, Manufacturing, Clinical, IT, and other functions on Quality Agreement provisions, and monitor supplier compliance with agreements.
Develop and maintain a risk-based supplier performance monitoring and scorecard program, including meaningful KPIs and quality metrics for critical suppliers.
Monitor supplier performance across SCARs, audit findings, deviations and quality events, CAPA effectiveness, change notifications, responsiveness, recurring issues, quality commitments, and Quality Agreement compliance.
Conduct periodic supplier performance reviews; communicate trends, risks, and recommendations to Quality leadership and cross-functional stakeholders; identify suppliers needing enhanced oversight or formal improvement plans.
Present supplier quality trends and significant risks during Quality Management Review and other governance forums.
Lead or coordinate SCARs for significant supplier quality issues; ensure containment, investigations, root cause analysis, corrective and preventive actions, and effectiveness verification are appropriate.
Assess supplier investigations and CAPA responses for scientific and technical adequacy; identify recurring issues and escalate significant quality, compliance, supply continuity, or patient-risk concerns.
Facilitate cross-functional supplier quality escalation meetings as needed and partner with suppliers to drive sustainable improvement.
Ensure supplier quality activities comply with applicable GxP requirements, company procedures, and Quality Agreements; integrate Supplier Quality with deviations, CAPA, change control, document control, training, Quality Management Review, and other QMS processes.
Evaluate supplier-related changes for potential impact to product quality, process performance, validated state, regulatory commitments, and supply continuity.
Develop and revise Supplier Quality procedures, forms, templates, risk-assessment tools, metrics, and training materials; maintain inspection-ready supplier quality records.
Support internal audits, partner audits, due diligence activities, and regulatory inspections involving supplier oversight.
Ensure qualification of GxP software, SaaS, cloud, and computerized-system suppliers evaluates validation and data-integrity controls, including system validation, audit trails, user access, electronic records, backup and recovery, subcontractors, and change notification as applicable.
Partner with Quality Systems, IT, system owners, and validation stakeholders when qualifying computerized systems and technology suppliers.