Associate Director, Inspection Readiness

Role Summary

Associate Director, Inspection Readiness. Reporting to the Director, Inspection Readiness, the Associate Director will help drive the strategy for Inspection Readiness and will, on a tactical level, execute compliance and inspection support programs in a matrixed organization. This role will also work collaboratively to monitor inspection trends and identify other compliance performance indicators across the network. This role will interact and collaborate extensively with teams and leaders across the BMS network. The Associate Director will support BMS' GMP/GDP Inspection Readiness strategy by supporting on-site and remote assessments of BMS internal and external sites, providing real-time support, based on a risk-based approach.

Responsibilities

• Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, and external signals, leveraging these insights to anticipate regulatory expectations, shape enterprise-wide inspection readiness strategies, and drive proactive, continuous improvement.
• Cultivate and sustain strategic partnerships with External Engagement, Quality Risk Management and Operations & Performance to identify, prioritize, and drive the implementation of initiatives that advance benchmark performance in automated predictive risk. Provide oversight to ensure alignment with organizational objectives and the integration of innovative solutions across the enterprise.
• Conduct independent enterprise reviews of regulatory interactions to objectively assess communications and commitments with health authorities, ensuring consistency, identifying gaps or risks, and enabling proactive remediation.
• Serve as a subject matter expert to review and advise on regulatory notification strategies by providing expert guidance on the interpretation and application of global regulatory requirements, as required.
• Develop and maintain strong partnerships with cross-functional teams and stakeholders across the end-to-end product lifecycle, from development through commercialization, to identify, share, and implement best practices and innovative solutions that advance benchmark inspection readiness and support a culture of quality and compliance.
• Perform comprehensive on-site or remote inspection readiness assessments at BMS sites and with external partners, utilizing standardized tools and methodologies to evaluate preparedness, reduce regulatory inspection risk, and provide expert inspection support and guidance as needed.
• Ensure the appropriate preparation, execution, and follow-up of inspection readiness activities so that sites and functions are fully inspection-ready. This includes overseeing pre-inspection audits, mock interviews, training sessions, storyboard reviews, logistics coordination, and the timely escalation of critical issues.
• Partner with site Quality and Compliance teams to prepare for and manage global regulatory inspections, including supporting the creation of comprehensive written responses to inspection observations and reports.
• Ensure the effective management of the GROe program to analyze audit and inspection findings, proactively reducing inspection risk, and coordinate across the enterprise to achieve end-to-end inspection readiness. Continuously identify opportunities to enhance and improve the GROe process.
• Lead or participate in sharing best practices and lessons learned, collaborate to standardize and improve processes, and motivate teams for strong inspection performance.

Qualifications

• A minimum of seven (7) years' experience in the Biopharm/Pharmaceutical industry with in-depth knowledge and experience in global auditing procedures and best practices.
• Bachelor's degree in Natural Science, Pharmacy, or related fields, required.
• Experience conducting inspections in pharmaceutical facilities and have worked for the US FDA within the past 10 years in a Consumer Safety Officer or similar role; minimum of 5 years' experience as a CSO required.
• Demonstrated negotiation, risk management, relationship management and conflict resolution skills.
• Proven ability to understand complex processes/problems and propose alternative solutions.
• Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
• Ability to work in a matrixed organization with diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals.
• Able to complete multiple projects with minimal supervision and prioritize incoming work appropriately.
• Proven track record of working across the network to find common solutions and drive positive impact for patients.
• In-depth knowledge of Global Health Authority regulations and quality systems principles as applied to the pharmaceutical industry.
• Strong communication and collaboration skills across all levels and formats.
• Proficiency in data analytics and advanced analytics tools.
• Travel up to 25%, may exceed this travel requirement if needed by the business.