Description:
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.