Director, Inspection Readiness

Role Summary

The Director of Inspection Readiness is responsible for ensuring organizational preparedness for regulatory agency inspections 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 to drive inspection readiness strategies, conduct gap analyses, and serve as a subject matter expert on compliance and regulatory inspection matters.

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.
• 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 the overall inspection preparedness of the 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

• Bachelor's degree in Natural Science, Pharmacy, or related fields, required.
• 10+ years of relevant experience in regulatory affairs, compliance, or quality assurance in the pharmaceutical, biotech, cell therapy, and medical device industries.
• Minimum of 5 years' experience as a Consumer Safety Officer (CSO) or in a similar role at the US FDA, with FDA employment within the past 10 years (2015-2025) required.
• Extensive experience conducting inspections in pharmaceutical (medical device, biologics) facilities.
• In-depth knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) and GxP standards.
• Exceptional leadership, communication, and influencing skills.
• Proven ability to develop and implement strategic programs and drive organizational change.
• Strong analytical and problem-solving abilities.
• Experience managing large, cross-functional global teams and projects.
• Experience with enterprise-level compliance systems and audit management tools.
• Demonstrated ability to manage multiple complex projects simultaneously.
• Recognized as a thought leader in regulatory inspection readiness within the industry.
• This position requires 30-50% travel.

Skills

• Regulatory affairs and quality assurance
• Inspection readiness and mock inspections
• Regulatory intelligence and trend analysis
• GxP compliance and global regulatory knowledge
• Project and program management
• Cross-functional collaboration and stakeholder management
• Communication with regulatory agencies

Education

• Bachelor's degree in Natural Science, Pharmacy, or related field