Senior Manager, Inspection Readiness

Senior Manager, Inspection Readiness role at Bristol Myers Squibb UK & Ireland. Reporting to the Director, Inspection Readiness, this position plays a critical role in advancing the organization\'s inspection readiness program. It 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.

• 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.
• Partner with External Engagement to adopt a proactive 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.
• Collaborate with Quality Risk Management to develop risk models identifying 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 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 GROe evaluations 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 Operations & Performance and BIT teams to identify and implement opportunities to advance benchmark performance for automated predictive risk.

• A minimum of five (5) years\' experience in the Biopharm/Pharmaceutical industry with knowledge of audits and inspections.
• Bachelor\'s degree in Natural Science, Pharmacy, or related field, required.
• Experience conducting inspections in pharmaceutical facilities and preferably work experience with US FDA as a Consumer Safety Officer (CSO) or similar role (minimum 2 years as CSO preferred).
• Proven ability to understand complex processes and propose alternate solutions.
• Innovation, flexibility, adaptability in a rapidly changing environment with shifting priorities.
• Strong communication, collaboration, negotiation, problem solving and interpersonal skills.
• Ability to work in a matrixed organization with diverse teams and influence areas not under direct control to achieve objectives.
• Track record of working across networks to find common solutions and drive positive impact for patients.
• Strong knowledge of Global Health Authority regulations, quality systems principles and applications to the pharmaceutical industry.
• Proficient in data visualization platforms and regulatory intelligence tools; able to deliver insights from data analytics and advanced analytics tools.
• Willingness to travel up to 15% (travel may exceed this if needed by the business).

Other notes: Information about compensation, benefits, on-site protocol, and equal opportunity statements are provided by the company on the careers site and related postings.