QA Manager, Audit and Inspection Managment

Job Description

Position Summary

The Quality Assurance Manager, Audits & Inspections is responsible for the planning, execution, management, and continuous improvement of the company’s GxP audit and regulatory inspection readiness programs supporting late-stage pharmaceutical development.

The role provides hands-on leadership for internal, external, vendor, and study-related audits and establishes a sustainable inspection-readiness program as the organization progresses through Phase 3 clinical development toward regulatory submission, pre-approval inspection, and commercialization readiness.

Working under the direction of the Head of Quality Assurance, the Manager partners with Clinical Operations, CMC, Regulatory Affairs, Pharmacovigilance, Nonclinical, and other functional teams to identify compliance risks, assess inspection readiness, manage audit observations and corrective actions, and ensure the organization and its critical service providers remain prepared for regulatory inspection.

This is a hands-on individual-contributor role requiring demonstrated experience conducting GxP audits and supporting FDA and/or other health-authority inspections.

Key Responsibilities

Audit Program Management

• Develop and maintain a risk-based annual and multi-year GxP audit program covering internal functions, clinical studies, CROs, CDMOs, laboratories, pharmacovigilance providers, and other critical GxP vendors.
• Plan, schedule, conduct, document, and close GxP audits in accordance with approved procedures and applicable regulatory requirements.
• Develop audit plans, agendas, checklists, reports, observations, and follow-up documentation.
• Evaluate audit observations for regulatory significance, systemic risk, and potential impact on product quality, subject protection, data integrity, and regulatory submissions.
• Track audit findings, commitments, CAPAs, and effectiveness activities through closure.
• Perform audit trending and provide periodic reporting of significant findings and emerging compliance risks to QA leadership.

Regulatory Inspection Readiness

• Develop and maintain the company’s inspection-readiness program for FDA and other applicable health authorities.
• Support readiness for BIMO, GCP, GMP, GLP, GVP and, as applicable, Pre-Approval Inspections (PAI).
• Conduct inspection-readiness assessments, mock inspections, document reviews, interview preparation, and functional readiness exercises.
• Identify potential inspection vulnerabilities and coordinate remediation activities with responsible functional owners.
• Maintain inspection-readiness tools, procedures, playbooks, request-management processes, and supporting documentation.
• Support development and maintenance of inspection war-room, document-request, response-review, escalation, and communication processes.

Regulatory Inspection Management

• Support the Head of Quality Assurance in coordinating and managing regulatory inspections.
• Facilitate inspection logistics, document requests, SME preparation, inspection-room activities, and real-time issue escalation.
• Review proposed responses and supporting evidence for accuracy, completeness, consistency, and regulatory defensibility.
• Support evaluation and response to inspection observations, including FDA Form 483 observations and comparable health-authority findings.
• Track post-inspection commitments and associated CAPAs through completion and effectiveness verification.

Vendor and Partner Quality Oversight

• Conduct qualification, routine, for-cause, and risk-based audits of CROs, CDMOs, laboratories, and other GxP service providers.
• Evaluate vendor audit findings in the context of sponsor oversight responsibilities and program risk.
• Partner with functional owners to establish appropriate remediation and escalation plans.
• Support vendor qualification and ongoing performance monitoring based on audit results, quality events, compliance history, and risk.

Compliance Risk & CAPA

• Identify emerging or systemic compliance risks through audit findings, inspection trends, quality events, and other quality intelligence.
• Support or lead root-cause investigations associated with significant audit and inspection findings.
• Review CAPAs for adequacy, proportionality, sustainability, and regulatory defensibility.
• Perform or coordinate CAPA effectiveness verification associated with audit and inspection observations.
• Escalate significant compliance risks promptly to the Head of Quality Assurance.

Cross-Functional Quality Partnership

• Serve as a hands-on QA resource to functional teams preparing for audits and regulatory inspections.
• Provide training and coaching to employees and SMEs regarding inspector interactions, documentation practices, inspection conduct, and response expectations.
• Collaborate with QMS and GxP QA program functions to translate audit and inspection findings into sustainable improvements to the Quality Management System.
• Maintain appropriate independence and objectivity when conducting audits and evaluating compliance.

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