Quality Audit Manager

The Role

Neurona is seeking a Quality Audit Manager who is responsible for the development, implementation, execution, and continuous improvement of Neurona Therapeutics’ GxP Quality Audit Program. Reporting to the Director, QA Systems, this individual provides strategic and operational leadership for internal audits, supplier and service-provider audits, contracted audit activities, partner assessments, due diligence audits, and inspection-readiness assessments supporting Neurona’s Quality Management System and cell therapy programs.

The Quality Audit Manager serves as the Quality Systems subject matter expert for audit planning, risk-based scheduling, audit preparation and execution, auditor qualification, audit reporting, observation classification, corrective action follow-up, audit closure, trend analysis, and inspection readiness. The role works cross-functionally to evaluate compliance, identify systemic risk, verify QMS effectiveness, and promote sustainable quality improvement. This position combines program ownership with hands-on audit execution. The role leads complex audits, establishes scalable audit governance, and provides management with clear, risk-based insight into findings, recurring compliance concerns, overdue actions, and organizational readiness.

Essential Duties and Responsibilities Include:

Audit Program Governance and Risk-Based Planning

• Own and administer Neurona’s GxP Quality Audit Program in accordance with applicable procedures, regulatory requirements, quality agreements, and business needs.
• Develop and maintain a rolling, risk-based audit strategy and annual audit schedule covering internal QMS audits, functional and process audits, supplier audits, computerized-system audits, partner assessments, due diligence activities, and for-cause audits.
• Establish audit frequency and scope based on product and patient risk, supplier criticality, compliance history, previous findings, operational changes, quality-event trends, regulatory commitments, and management priorities.
• Maintain an audit universe identifying auditable functions, processes, facilities, suppliers, systems, and external partners.
• Ensure audit plans are adequately resourced with qualified auditors and relevant subject-matter experts.
• Present the audit strategy, program status, and material schedule changes to Quality leadership.

Internal Audit Management

• Plan, lead, and document risk-based audits of Neurona departments, quality systems, processes, records, and computerized systems.
• Develop audit objectives, scope, criteria, agendas, sampling plans, interview strategies, and documentation requests.
• Evaluate QMS processes including deviations, investigations, RCA, CAPA, change control, OOS, data integrity, training, document control, supplier quality, Quality Management Review, validation, audit trails, access controls, and product-quality monitoring.
• Conduct opening meetings, interviews, record reviews, facility walkthroughs, daily debriefs, and closing meetings.
• Apply consistent risk-based criteria to classify observations as critical, major, minor, or opportunities for improvement.
• Prepare clear, evidence-based observations identifying the requirement, objective evidence, deficiency, risk, and affected system.

External, Supplier, and Partner Audits

• Plan, lead, support, or coordinate qualification, routine, surveillance, directed, and for-cause audits of GxP suppliers and service providers.
• Audit CMOs/CDMOs, contract laboratories, critical-material suppliers, clinical service providers, logistics providers, consultants, and GxP software or cloud suppliers, as applicable.
• Coordinate audit dates, confidentiality requirements, teams, agendas, document requests, logistics, and stakeholder participation.
• Evaluate quality systems, technical capabilities, validation and data-integrity controls, regulatory history, subcontractor controls, change notification, and compliance with quality agreements.
• Prepare or review audit reports and ensure observations are accurate, appropriately classified, and supported by objective evidence.
• Review supplier responses and CAPA plans for completeness, root cause adequacy, sustainable correction, and effectiveness verification.
• Coordinate and oversee qualified third-party auditors when contract resources are used.

Lead Auditor Responsibilities

• Serve as Lead Auditor for complex, high-risk, or cross-functional audits.
• Select qualified, independent audit-team members and technical experts.
• Assign responsibilities and ensure the team understands the approved scope, criteria, methods, and documentation expectations.
• Maintain control of scope and sampling while appropriately following emerging evidence and potential systemic concerns.
• Ensure audit records document personnel interviewed, records reviewed, facilities observed, samples selected, and evidence supporting conclusions.
• Resolve differences among audit-team members and ensure conclusions are consistent and defensible.
• Protect confidential, proprietary, patient, subject, employee, and supplier information obtained during audits.

Audit Findings, CAPA Follow-Up, and Closure

• Maintain a controlled process for issuance, review, response, escalation, and closure of audit findings.
• Evaluate responses for correction and containment, impact assessment, investigation scope, evidence-based root cause, cross-functional impact, CAPA, ownership, due dates, and effectiveness checks.
• Ensure critical and major findings receive timely escalation and documented management oversight.
• Track audit commitments, CAPAs, and effectiveness checks through closure.
• Challenge responses that rely primarily on retraining, reminders, or human error without addressing underlying process, procedure, technical, or governance deficiencies.
• Verify completed actions through objective evidence and confirm closure is based on satisfactory remediation.
• Identify and escalate repeat findings, recurring root causes, ineffective CAPAs, and systemic control failures.

Regulatory Inspection and Partner-Assessment Readiness

• Own or support the organizational inspection-readiness program.
• Conduct readiness assessments, mock inspections, process walkthroughs, and targeted procedure or record reviews.
• Maintain inspection plans, notification lists, front-room and back-room procedures, request workflows, SME assignments, role responsibilities, status trackers, and mock interview materials.
• Train employees and SMEs on inspection conduct, document presentation, question handling, escalation, and Good Documentation Practices.
• Support regulatory inspections, partner audits, baseline assessments, and due diligence reviews.
• Facilitate daily debriefs and ensure requests, observations, commitments, and follow-up actions are accurately documented.
• Support preparation and review of responses to regulatory or partner observations.

Audit Metrics, Trending, and Management Reporting

• Develop and maintain audit KPIs, including plan adherence, report timeliness, findings by classification and QMS area, response timeliness, overdue actions, repeat observations, root-cause trends, effectiveness, and closure cycle time.
• Analyze cross-audit trends to identify recurring or systemic compliance risk.
• Translate audit data into clear management insights and recommended actions.
• Present audit-program status, significant findings, overdue actions, repeat observations, and emerging risks during Quality Management Review and other governance forums.
• Recommend targeted audits, escalation, procedural improvements, and risk-reduction initiatives based on trends.

Audit Systems, Records, and Data Integrity

• Maintain audit plans, schedules, agendas, reports, responses, evidence, approvals, and closure records in Qualio or another approved system of record.
• Ensure audit records are complete, controlled, searchable, traceable, confidential, retained appropriately, and inspection-ready.
• Establish standardized metadata for audit type, scope, function, supplier, finding classification, affected system, root cause, CAPA linkage, due date, status, and closure.
• Maintain standardized templates for plans, agendas, checklists, notes, reports, responses, CAPA evaluations, closure memoranda, and management reporting.
• Promote data integrity and ALCOA++ principles throughout audit documentation and record management.

Quality Systems and Continuous Improvement

• Use audit results to evaluate the ongoing suitability and effectiveness of the Quality Management System.
• Partner with process owners to convert audit findings and trends into sustainable improvements.
• Support revision of audit, CAPA, inspection-readiness, supplier-quality, and related procedures.
• Monitor relevant regulatory developments, enforcement trends, inspection findings, and industry practices.
• Incorporate regulatory intelligence and lessons learned into audit planning, auditor training, and inspection readiness.
• Support special Quality Systems projects and QMS remediation initiatives assigned by the Director, QA Systems.