Senior Manager, Inspection Readiness

Senior Manager, Inspection Readiness at Bristol Myers Squibb is a role that supports the organization's inspection readiness program. Reporting to the Director, Inspection Readiness, the Senior Manager leverages data analytics, regulatory trends, and quality insights to proactively identify and mitigate risks, inform strategic decisions, and drive continuous improvement across the GxP enterprise. The Senior Manager serves as a link between regulatory intelligence, quality systems, and operational readiness, ensuring preparedness for 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, using 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 to enable data-driven decisions and support the transition to a predictive quality organization.
• Develop risk models with Quality Risk Management 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, 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 with data-driven insights.
• Promote communication 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 and efficiency 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 of experience in the Biopharm/Pharmaceutical industry with knowledge of audits and inspections.
• Bachelor's degree in Natural Science, Pharmacy, or related fields, required.
• Experience conducting inspections in pharmaceutical facilities (medical device, biologics); ideally with experience at the US Food and Drug Administration (FDA) within the past 5 years in a Consumer Safety Officer (CSO) or similar role; minimum of 2 years in a CSO role preferred.
• Ability to understand complex processes and propose alternate solutions; demonstrated innovation, flexibility, and adaptability in a rapidly changing environment.
• Strong communication, collaboration, negotiation, problem-solving and interpersonal skills; ability to work in a matrixed, global organization and influence across teams.
• Knowledge of Global Health Authority regulations and quality systems; proficient in data visualization platforms and regulatory intelligence tools; able to deliver insights from data analytics.
• Travel: up to 15%, may exceed this requirement if needed by the business.

Locations: Devens, MA; New Brunswick, NJ; Princeton, NJ. Salary ranges listed as starting compensation for a full-time employee: Devens - MA: $149,010 - $180,569, New Brunswick - NJ: $139,260 - $168,755, Princeton - NJ: $139,260 - $168,755. Additional incentive cash and stock opportunities may be available based on eligibility.

• Medical, dental, vision care; wellbeing programs; 401(k); disability and life insurance; travel protection.
• Paid holidays, vacation, volunteer days, sick time, and flexible work arrangements where applicable.
• Parental, caregiver, bereavement, military leave; adoption and surrogacy reimbursement; fertility benefits; travel mother support; child, elder and pet care resources; tuition reimbursement; recognition programs.

Uniquely Interesting Work, Life-changing Careers: Bristol Myers Squibb emphasizes transforming patients' lives through science and empowering employees to contribute their talents in a diverse, inclusive culture.