Director, Inspection Readiness

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Position Summary:

The Director of Inspection Readiness is responsible for ensuring organizational preparedness for regulatory agency inspections (e.g., FDA, EMA, PMDA, etc.) across global pharmaceutical, biologics, cell therapy, and medical device operations. Reporting to the Senior Director of Inspection Readiness, this individual contributor role leverages extensive industry and  regulatory experience to drive inspection readiness strategies, conduct gap analyses, and serve as a subject matter expert on regulatory compliance and health authority inspection matters.

Duties and Responsibilities

• Support the Senior Director of Inspection Readiness to drive the development, execution, and ongoing evolution of a Global Quality inspection readiness strategy that embeds an “always‑ready” state of compliance.

• 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.

•  Ensure inspection‑ready narratives and defensible decision‑making are clearly articulated, demonstrated, and sustained in practice.

• Support the Senior Director as a recognized expert advisor and point of escalation for sites during regulatory inspections, delivering real‑time support and expert review, challenge, and alignment of inspection responses and remediation actions prior to submission to the health authority.

• 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.

• Serve as a trusted regulatory compliance advisor, guiding regulatory notification strategies, event escalation decisions, and inspection readiness activities to ensure alignment with global health authority expectations.

• Establish and maintain a network of industry contacts to benchmark and adopt best practices in inspection readiness.

Qualifications and skills required:

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

• 10+ years of progressive experience in regulatory compliance and QA/QC, including leadership responsibility, within the pharmaceutical, biologics, cell therapy, and medical device industries.

• Experience planning, leading, and conducting internal audits of pharmaceutical manufacturing sites and laboratories.

• Demonstrated experience supporting Health Authority inspections (e.g., FDA, EMA, MHRA, PMDA), including roles as inspection facilitator/lead, front‑room SME, and back‑room support, with responsibility for inspection readiness, logistics, data management, and cross‑functional regulatory interactions.

• In-depth knowledge of global regulatory requirements (FDA, EMA, PMDA, NMPA, etc.) and GxP standards.

• Exceptional leadership, communication, and influencing skills.

• Pr