Title: Supplier Quality Manager (Quality Systems)Location: South San Francisco, CA
Work Type: On-site
Salary Range: $140,000 - $150,000
The Role:Neurona is seeking a Supplier Quality Manager who is responsible for the development, implementation, execution, and continuous improvement of Neurona Therapeutics' Supplier Quality Management program. Reporting to the Director, QA Systems, this individual provides Quality oversight of GxP suppliers, vendors, service providers, contract organizations, and other external partners supporting the development and manufacture of Neurona's cell therapy products.
The Supplier Quality Manager serves as the Quality Systems subject matter expert for supplier qualification, risk assessment, supplier audits, quality agreements, ongoing performance monitoring, Supplier Corrective Action Requests (SCARs), and periodic requalification. This role partners closely with Quality, Manufacturing, Supply Chain, Technical Operations, CMC, Clinical, Information Technology, and other functions to ensure externally provided materials and services meet Neurona requirements and applicable regulatory expectations.
This position combines program ownership with hands-on execution and is expected to build a scalable, risk-based supplier quality program appropriate for a growing clinical-stage cell therapy organization.
Essential Duties and Responsibilities Include:
Supplier Qualification and Lifecycle Management- Own and administer the GxP supplier and vendor qualification program in accordance with applicable Neurona procedures and regulatory requirements.
- Lead the 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 potential risk to product quality, patient safety, data integrity, and regulatory compliance.
- Establish qualification requirements based on supplier type, criticality, intended use, and GxP risk.
- Ensure qualification decisions and supporting documentation are complete, traceable, and inspection ready.
- Maintain supplier qualification status and applicable records in the electronic Quality Management System, including the Approved Vendor List.
Supplier Audits- Support the development and maintenance of a risk-based supplier audit program and audit schedule.
- Support planning, conducting, and documenting on-site, remote, and qualification audits of GxP suppliers and service providers.
- Support regulatory inspections and partner audits involving supplier oversight.
Supplier Quality Agreements- Lead the preparation, review, negotiation, approval, maintenance, and periodic review of GxP Quality Agreements.
- Ensure Quality Agreements clearly define responsibilities for deviations, investigations, CAPAs, change notification, complaints, data integrity, records, audits, subcontracting, regulatory inspections, and other applicable quality requirements.
- Partner with Legal, Supply Chain, CMC, Manufacturing, Clinical, IT, and other functions to establish appropriate provisions.
- Monitor supplier compliance with established Quality Agreement requirements.
Supplier Performance Management- Develop and maintain a risk-based supplier performance monitoring and scorecard program.
- Establish meaningful KPIs and quality metrics for critical suppliers.
- Monitor performance across SCARs, audit findings, deviations and quality events, CAPA effectiveness, change notifications, responsiveness, recurring issues, delivery of quality commitments, and compliance with Quality Agreements.
- Conduct periodic supplier performance reviews and communicate trends, risks, and recommendations to Quality leadership and cross-functional stakeholders.
- Identify suppliers requiring enhanced oversight or formal improvement plans.
- Present supplier quality trends and significant risks during Quality Management Review and other governance forums.
Supplier Corrective Action and Escalation- Lead or coordinate Supplier Corrective Action Requests for significant supplier quality issues.
- Ensure appropriate containment, investigation, root cause analysis, corrective and preventive actions, and effectiveness verification.
- Assess supplier investigation 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 necessary.
- Partner with suppliers to drive sustainable improvement rather than relying solely on correction or retraining.
Quality Systems and Compliance- Ensure supplier quality activities are conducted in accordance 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 supplier quality records in an inspection-ready state.
- Support internal audits, partner audits, due diligence activities, and regulatory inspections involving supplier oversight.
Data Integrity and Computerized-System Supplier Oversight- Ensure qualification of GxP software, SaaS, cloud, and computerized-system suppliers appropriately evaluates validation and data-integrity controls.
- Assess supplier practices related to system validation, audit trails, user-access management, electronic records, backup and recovery, subcontractors, and change notification, as applicable.
- Ensure supplier assessments address relevant data integrity expectations and appropriate controls for technologies supporting GxP activities.
- Partner with Quality Systems, IT, system owners, and validation stakeholders when qualifying computerized systems and technology suppliers.
Required Qualifications:- 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.
- Minimum 3 years of direct experience with supplier or vendor quality management, 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.
Preferred Qualifications:- 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.
Knowledge, Skills, and Abilities:- 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.
- Demonstrated 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 with the ability to manage multiple suppliers, audits, quality agreements, and deliverables concurrently.
- Ability to develop pragmatic solutions suitable 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.
Interested in learning more about our science and our team? Please visit our website at www.neuronatherapeutics.com.
