Director, Inspection Readiness

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The Director of Inspection Readiness is responsible for ensuring organizational preparedness for regulatory agency inspections (e.g., FDA, EMA, PMDA, etc.) across global pharmaceutical, biotech, cell therapy, and medical device operations. Reporting to the Senior Director of Inspection Readiness, this individual contributor role leverages extensive regulatory experience, including prior service as a Consumer Safety Officer (CSO) or similar role with the US Food & Drug Administration (FDA), to drive inspection readiness strategies, conduct gap analyses, and serve as a subject matter expert on compliance and regulatory inspection matters.

Duties and responsibilities:

• 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. 

• Works 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. 

Qualifications and requirements:

• Bachelor’s degree in Natural Science, Pharmacy, or related fields, required.

• 10+ years of relevant experience in regulatory affairs, complia