Director

• Ensure organizational preparedness for regulatory agency inspections (e.g., FDA, EMA, PMDA, etc.) across global pharmaceutical, biotech, cell therapy, and medical device operations.
• Support the Senior Director of Inspection Readiness to develop, implement, and continuously enhance the Global Quality inspection readiness strategy and framework.
• Conduct mock inspections, gap analyses, and assessments of inspection readiness for facilities and business units.
• Monitor regulatory intelligence, trends, and changes, integrating Predictive Quality insights to adapt inspection readiness strategies and maintain proactive compliance.
• Consolidate and analyze regulatory observations and lessons learned to inform continuous improvement and prevent repeat observations.
• Support the Senior Director as an expert advisor and point of contact for site guidance during regulatory inspections, providing real-time support, high-level oversight of inspection conduct, response management, remediation activities, and direct communication with regulatory agencies.
• Collaborate with cross-functional stakeholders to ensure integrated inspection preparedness across all business units.
• Analyze inspection outcomes and drive post-inspection improvement initiatives.
• Work with site principals to ensure effective, local, Inspection Readiness plans are developed and maintained.
• Develop robust metrics that best measure the performance of the Inspection Readiness program and that measures the overall inspection preparedness of the BMS Network.
• Champion a culture of compliance, quality, and continuous improvement throughout the organization.
• Responsible for the management and execution of the GROe process.
• Advise on compliance matters by providing guidance on regulatory notifications, escalation of events, and readiness for regulatory inspections.
• Establish and maintain a network of industry contacts to benchmark and adopt best practices in inspection readiness.

Director, Inspection Readiness

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