Senior Manager, Inspection Readiness

Role Summary

Reporting to the Director, Inspection Readiness, the Senior Manager, Inspection Readiness plays a critical role in advancing the organization's inspection readiness program. This position leverages data analytics, regulatory trends, and quality insights to proactively identify and mitigate risks, inform strategic decision-making, and drive continuous improvement across the GxP enterprise. The Senior Manager serves as a key link between regulatory intelligence, quality systems, and operational readiness, ensuring the organization remains prepared for and responsive to evolving global regulatory expectations.

Responsibilities

• Monitor and assess global regulatory inspection outcomes, enforcement actions, and emerging trends to inform inspection readiness strategies.
• Benchmark internal performance against industry standards and regulatory expectations, utilizing connectivity to internal, external, and Quality Risk Management (QRM) data.
• In partnership with the External Engagement team adopt a proactive and preventative approach to inspection readiness through continuous surveillance of regulatory changes and inspection activity, leveraging external data and intelligence.
• Translate insights into actionable recommendations for the Inspection Readiness team, enabling informed, data-driven decisions and supporting the transition to a predictive quality organization.
• In collaboration with Quality Risk Management develop risk models to identify high-risk areas, processes, or sites, strengthening inspection readiness.
• Collaborate with site Quality and Compliance teams to prioritize readiness activities based on intelligence and analysis.
• Support the preparation, execution, and follow-up of inspection readiness activities to ensure sites and functions are inspection-ready, including pre-inspection audits, mock interviews, training, storyboard review, logistics, and escalation of critical issues.
• Disseminate timely alerts and updates to stakeholders, provide intelligence briefings and targeted preparation materials for Subject Matter Experts (SMEs), and support mock inspections and readiness training with data-driven insights.
• Promote communication and awareness of inspection risks and mitigation strategies via applicable forums e.g. Compliance Community of Practice, Quality Council.
• Lead Global Regulatory Observation evaluations (GROe) to drive timely assessment, proactive compliance, and risk mitigation at BMS sites.
• Seek opportunities for simplification, efficiency and enhancements across the GROe process.
• Provide Inspector Intelligence Reports and monitor the Regulatory Inspection Mailbox.
• Develop and maintain partnerships with the Operations & Performance and BIT teams to identify and implement opportunities to advance benchmark performance for automated predictive risk.

Qualifications

• Required: A minimum of five (5) years' experience in the Biopharm/Pharmaceutical industry with knowledge of audits and inspections.
• Required: Bachelor's degree in Natural Science, Pharmacy, or related fields.
• Preferred: Previously conducted inspections in pharmaceutical facilities and preferably worked for the US FDA within the past 5 years (2015-2025) in a Consumer Safety Officer (CSO) or similar role; minimum of 2 years' experience as a CSO preferred.
• Required: Proven ability to understand complex processes/problems and propose alternate solutions.
• Required: Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
• Required: Strong communication, collaboration, negotiation, problem solving and interpersonal skills.
• Required: Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Required: Has a proven track record of working across the network to find common solutions and drive positive impact and benefits for patients.
• Required: Strong knowledge of Global Health Authority regulations, quality systems principles and applications to the pharmaceutical industry.
• Required: Proficient in data visualization platforms and regulatory intelligence tools.
• Required: Proficiency in delivering insights from data analytics and advanced analytics tools.
• Required: Demonstrated ability to work cross-functionally in a matrixed, global organization, influencing technically, culturally, and geographically diverse teams.

Additional Requirements

• Travel up to 15%, may exceed this travel requirement, if needed by the business.