Senior Manager, Inspection Readiness

Overview 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.
Key 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.
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.
Qualifications & Experience 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.

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