Senior Manager, Inspection Readiness

Snr. Manager, Inspection Readiness

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Position Summary

Reporting to the Director, Inspection Readiness, the Snr. 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 Snr. 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.

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 & 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 fields, required.

The candidate will have previously conducted inspections in pharmaceutical (medical device, biologics) facilities and have preferably worked for the US Food & Drug Administration (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.

Proven ability to understand complex processes / problems and propose alternate solutions.

Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.

Strong communication, collaboration, negotiation, problem solving and interpersonal skills.

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.

Has a proven track record of working across the network to find common solutions and drive positive impact and benefits 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.

Proficiency in delivering insights from data analytics and advanced analytics tools.

Demonstrated ability to work cross-functionally in a matrixed, global organization, influencing technically, culturally, and geographically diverse teams.

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