Quality Audit Manager

Neurona Therapeutics•South San Francisco, CA

1h•$140,000 - $150,000•Onsite

About The Position

Neurona Therapeutics is seeking a Quality Audit Manager to own and continuously improve the company’s GxP Quality Audit Program. Reporting to the Director, QA Systems, the role provides strategic and operational leadership for internal, supplier, service-provider, contracted, partner, due diligence, and inspection-readiness audits supporting the Quality Management System and cell therapy programs. The position combines audit-program ownership with hands-on audit execution. The manager leads complex, high-risk audits; establishes risk-based planning, governance, and reporting; evaluates compliance and QMS effectiveness; follows findings and corrective actions through closure; and provides Quality leadership with clear insight into findings, recurring risks, overdue actions, and organizational readiness. The role also owns or supports inspection readiness, mock inspections, audit metrics and trend analysis, audit records and systems, auditor qualification, and continuous improvement. It works across functions and with external partners to identify systemic risks, verify sustainable remediation, and support the ongoing suitability and effectiveness of the Quality Management System.

Requirements

Bachelor’s degree in Life Sciences, Biotechnology, Engineering, Chemistry, Quality, Pharmacy, or another relevant scientific or technical discipline.
Approximately 7 or more years of progressively responsible experience in Quality Assurance, Quality Systems, Compliance, Auditing, Manufacturing Quality, Clinical Quality, or a related GxP function.
At least 3 years of direct auditing experience, including planning, conducting, reporting, and closing GxP audits.
Demonstrated experience serving as Lead Auditor for internal, supplier, quality-system, or regulated-service-provider audits.
Working knowledge of GMP and other applicable GxP requirements in biotechnology, pharmaceutical, biologics, cell or gene therapy, medical device, or another regulated life-sciences environment.
Experience evaluating deviations, investigations, root cause analyses, CAPAs, change controls, data-integrity controls, training systems, and management oversight.
Experience writing evidence-based observations and evaluating corrective action responses.
Experience managing multiple audits, findings, action plans, and deadlines concurrently.
Strong working knowledge of risk-based GxP auditing and Quality Management Systems.
Knowledge of applicable FDA regulations and guidance, ICH quality principles, and current Good Manufacturing Practices.
Familiarity with 21 CFR Parts 11, 210, 211, 600, and applicable elements of Part 820, as relevant.
Familiarity with ICH Q9(R1), ICH Q10, data-integrity expectations, and inspection-readiness principles.
Strong understanding of deviations, investigations, CAPA, change control, OOS, data integrity, document control, training, supplier quality, and Quality Management Review.
Ability to distinguish isolated documentation errors from systemic or recurring control failures and assess risk to patient or subject safety, product quality, data integrity, regulatory commitments, and validated state.
Strong interviewing, sampling, evidence-evaluation, technical-writing, and report-writing skills.
Strong judgment and ability to communicate difficult findings objectively and professionally.
Ability to remain independent, maintain constructive working relationships, and influence without direct authority.
Strong project-management, organizational, prioritization, written, and verbal communication skills.

Nice To Haves

Experience in cell therapy, gene therapy, biologics, or other advanced therapeutic products.
Experience supporting a clinical-stage biotechnology company progressing toward late-stage development or commercial readiness.
Experience auditing CMOs, CDMOs, contract laboratories, clinical service providers, GxP software suppliers, and other regulated external partners.
Experience preparing for or supporting FDA, EMA, partner, or other health-authority inspections.
Experience developing and facilitating mock inspections and inspection-readiness training.
Experience with electronic Quality Management Systems.
Auditor or Lead Auditor certification or formal training.
ASQ CQA, ASQ CMQ/OE, Exemplar Global, IRCA, or another relevant quality or audit credential.
Experience developing audit metrics, dashboards, and Quality Management Review content.

Responsibilities

Own and administer the GxP Quality Audit Program in accordance with procedures, regulatory requirements, quality agreements, and business needs.
Develop and maintain a rolling, risk-based audit strategy and annual schedule covering internal, functional, process, supplier, computerized-system, partner, due diligence, and for-cause audits.
Determine audit frequency and scope based on product and patient risk, supplier criticality, compliance history, prior findings, operational changes, quality trends, regulatory commitments, and management priorities.
Maintain an audit universe of auditable functions, processes, facilities, suppliers, systems, and external partners; ensure audit plans have qualified auditors and relevant subject-matter experts; and report strategy and program status to Quality leadership.
Plan, lead, and document risk-based audits of departments, QMS processes, records, and computerized systems, including defining objectives, scope, criteria, agendas, sampling plans, interview strategies, and document requests.
Conduct audit meetings, interviews, record reviews, facility walkthroughs, debriefs, and closing meetings; evaluate relevant QMS processes and classify observations consistently using risk-based criteria.
Prepare clear, evidence-based audit observations that identify applicable requirements, objective evidence, deficiencies, risk, and affected systems.
Plan, lead, support, or coordinate qualification, routine, surveillance, directed, and for-cause audits of GxP suppliers and service providers, including external manufacturers, laboratories, clinical providers, logistics providers, consultants, and GxP software or cloud suppliers as applicable.
Coordinate audit logistics and stakeholder participation; evaluate external partners’ quality systems, technical capabilities, validation and data-integrity controls, regulatory history, subcontractor controls, change notification, and quality-agreement compliance.
Prepare or review audit reports, assess supplier responses and CAPA plans, oversee third-party auditors when used, and verify that findings and remediation are accurately documented and supported by evidence.
Serve as Lead Auditor for complex, high-risk, or cross-functional audits; select qualified and independent team members, assign responsibilities, maintain appropriate scope and sampling, resolve team differences, and ensure defensible conclusions and complete audit records.
Protect confidential, proprietary, patient, subject, employee, and supplier information obtained during audits.
Maintain a controlled process for issuance, review, response, escalation, and closure of audit findings and track commitments, CAPAs, and effectiveness checks through closure.
Evaluate responses for containment, impact assessment, investigation scope, root cause, cross-functional impact, CAPA, ownership, due dates, and effectiveness checks; escalate critical and major findings and challenge inadequate corrective actions.
Verify remediation through objective evidence and escalate repeat findings, recurring root causes, ineffective CAPAs, and systemic control failures.
Own or support organizational inspection readiness, including readiness assessments, mock inspections, process walkthroughs, procedure and record reviews, inspection plans, request workflows, SME assignments, 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 inspection debriefs and document requests, observations, commitments, follow-up actions, and responses accurately.
Develop and maintain audit KPIs, analyze cross-audit trends, and present program status, significant findings, overdue actions, repeat observations, and emerging risks at Quality Management Review and other governance forums.
Maintain complete, controlled, searchable, traceable, confidential, appropriately retained, and inspection-ready audit records in Qualio or another approved system of record.
Establish standardized audit metadata and templates, and promote ALCOA++ data-integrity principles in audit documentation and record management.
Use audit results to evaluate QMS effectiveness and partner with process owners on sustainable improvements; support revisions to audit, CAPA, inspection-readiness, supplier-quality, and related procedures.
Monitor regulatory developments, enforcement trends, inspection findings, and industry practices, incorporating relevant intelligence into audit planning, auditor training, and inspection readiness.
Support Quality Systems projects and QMS remediation initiatives assigned by the Director, QA Systems.