QA Manager, Audit and Inspection Managment

Intuitive•Sunnyvale, CA

About The Position

The Quality Assurance Manager, Audits & Inspections is responsible for planning, executing, managing, and continuously improving 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 keep the organization and its critical service providers 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.

Requirements

Bachelor’s degree in life sciences, pharmacy, chemistry, engineering, or another relevant discipline.
Minimum of 7 years of progressive pharmaceutical, biotechnology, or regulated life-sciences Quality Assurance experience.
Hands-on experience planning, conducting, documenting, and closing GxP audits.
Experience auditing CROs, CDMOs, laboratories, clinical sites, or other regulated service providers.
Experience supporting FDA or other health-authority regulatory inspections.
Strong working knowledge of applicable FDA regulations, ICH guidance, and GxP requirements.
Experience with audit observations, investigations, CAPA development, remediation, and effectiveness verification.
Strong technical writing skills and ability to produce clear, evidence-based audit reports and compliance assessments.
Ability to independently evaluate complex compliance issues and appropriately escalate significant risks.
Strong auditor judgment and independence, attention to detail, regulatory and compliance acumen, concise technical writing, effective interviewing skills, and ability to distinguish isolated procedural deficiencies from systemic compliance risk.
Ability to challenge conclusions when warranted while maintaining productive working relationships with operational teams.

Nice To Haves

Experience supporting Phase 3 and late-stage pharmaceutical development.
Experience preparing for or supporting FDA BIMO and/or Pre-Approval Inspections (PAI).
Cross-functional auditing experience spanning GCP, GMP, GLP, and/or GVP.
Experience with clinical-stage organizations operating through outsourced CRO/CDMO models.
Experience developing or implementing formal inspection-readiness programs.
Lead Auditor certification, ASQ certification, RQAP, or comparable professional credential; desirable but not required.

Responsibilities

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; trend audit results and report significant findings and emerging compliance risks to QA leadership.
Develop and maintain the company’s inspection-readiness program for FDA and other applicable health authorities, including readiness for BIMO, GCP, GMP, GLP, GVP and, as applicable, Pre-Approval Inspections.
Conduct inspection-readiness assessments, mock inspections, document reviews, interview preparation, and functional readiness exercises; identify vulnerabilities and coordinate remediation.
Maintain inspection-readiness tools, procedures, playbooks, request-management processes, and supporting documentation, including inspection-room, document-request, response-review, escalation, and communication processes.
Support the Head of Quality Assurance in coordinating regulatory inspections, including logistics, document requests, SME preparation, inspection-room activities, and real-time issue escalation.
Review proposed inspection responses and supporting evidence for accuracy, completeness, consistency, and regulatory defensibility; support responses to FDA Form 483 observations and comparable findings.
Track post-inspection commitments and associated CAPAs through completion and effectiveness verification.
Conduct qualification, routine, for-cause, and risk-based audits of CROs, CDMOs, laboratories, and other GxP service providers; evaluate findings in the context of sponsor oversight responsibilities and program risk.
Partner with functional owners on vendor remediation and escalation plans and support vendor qualification and ongoing performance monitoring.
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 and promptly escalate significant compliance risks to the Head of Quality Assurance.
Serve as a hands-on QA resource to functional teams preparing for audits and inspections; train and coach employees and SMEs on inspector interactions, documentation practices, inspection conduct, and response expectations.
Collaborate with QMS and GxP QA program functions to translate findings into sustainable Quality Management System improvements.
Maintain independence and objectivity when conducting audits and evaluating compliance; escalate matters requiring significant regulatory interpretation, acceptance of material compliance risk, or final compliance disposition to the Head of Quality Assurance before communicating a final QA position.