Manager

• Reporting to the Director, Inspection Readiness and advancing the organization’s inspection readiness program.
• Leverage data analytics, regulatory trends, and quality insights to proactively identify and mitigate risks and inform strategic decision-making.
• Serve as a link between regulatory intelligence, quality systems, and operational readiness to ensure preparedness for 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 QRM data.
• Adopt a proactive and preventative approach to inspection readiness through surveillance of regulatory changes and inspection activity.
• Translate insights into actionable recommendations and support transition to a predictive quality organization.
• Develop risk models in collaboration with Quality Risk Management to identify high-risk areas, processes, or sites.
• Collaborate with site Quality and Compliance teams to prioritize readiness activities and support preparation, execution, and follow-up of inspection readiness activities.
• Disseminate timely alerts and updates, provide intelligence briefings and targeted preparation materials for SMEs, and support mock inspections and readiness training with data-driven insights.
• Lead Global Regulatory Observation evaluations (GROe) and 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 implement automated predictive risk opportunities.

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