Senior Manager, Inspection Readiness

Core Purpose:

• Design, lead, and sustain an enterprise inspection readiness program that ensures continuous regulatory readiness across all sites, functions, and GxP areas.
• Define and maintain inspection readiness strategies aligned with global health authority expectations and ensure consistent inspection behaviors, messaging, and documentation practices across the organization.
• Define governance and enterprise use cases for digital tools, AI, and inspection readiness platforms, including Microsoft Copilot and ACE software.

Essential Duties and Responsibilities:

• Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.
• Design and govern enterprise mock inspection and inspection readiness audit programs that assess system maturity and regulatory mindset rather than checklist compliance.
• Establish enterprise methods for inspection risk identification and trending using deviations, investigations, CAPAs, audit outcomes, repeat observations, and quality system data.

Education Requirements and Qualifications:

• Bachelor’s degree in science, engineering, or related discipline required; 8+ years of experience in pharmaceutical or biotech quality, compliance, or regulatory functions, including progressive leadership roles required.
• Strong knowledge of global regulatory inspection expectations and quality systems