Job DescriptionPosition SummaryThe 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 ResponsibilitiesAudit 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.
- Promptly escalate requests 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.
QualificationsRequired Qualifications - 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.
- Demonstrated hands-on experience planning, conducting, documenting, and closing GxP audits.
- Experience conducting audits of CROs, CDMOs, laboratories, clinical sites, or other regulated service providers.
- Demonstrated 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.
Preferred Qualifications- 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 is desirable but not required.
Key CompetenciesThe successful candidate should demonstrate strong auditor judgment and independence, exceptional attention to detail, regulatory and compliance acumen, concise technical writing, effective interviewing skills, and the ability to distinguish between isolated procedural deficiencies and systemic compliance risk. The individual must be comfortable challenging conclusions when warranted while maintaining productive working relationships with operational teams.
Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
