Dir External Manufacturing Regulatory Oversight

Position Summary

The Director, External Manufacturing Regulatory Compliance Oversight, provides independent regulatory compliance oversight, risk visibility, inspection-readiness support, governance, and organizational learning across the Innovative Medicine External Manufacturing network. The role partners with External Manufacturing Operations, Quality, Supply Chain, Procurement, Regulatory Affairs, Technical Operations, and other stakeholders to identify emerging compliance risks, strengthen compliance performance, and support proactive risk management across contract manufacturers, contract laboratories, strategic partners, and other external suppliers. This role operates within the External Manufacturing Regulatory Compliance Oversight organization and supports implementation of the compliance oversight strategy established for the network. The Director provides independent assessments, compliance challenge, and risk-based recommendations to improve regulatory compliance, inspection readiness, and remediation effectiveness. The role supports the broader IMRC mission of increasing risk visibility, strengthening governance, preventing recurrence of significant observations, and ensuring lessons learned are effectively deployed across the external manufacturing network.

Mission

Strengthen regulatory compliance across the External Manufacturing network through proactive, risk-based oversight, independent assessment of compliance risks, inspection-readiness support, remediation effectiveness oversight, and deployment of organizational learning that improves compliance performance across external partners.

Key Responsibilities

Risk Visibility, Oversight & Escalation

• Monitor and assess significant compliance risks across assigned external manufacturing partners.
• Identify emerging risk signals, recurring observations, inspection readiness concerns, and remediation trends.
• Conduct independent risk assessments and provide objective compliance challenge to accountable functions.
• Support escalation and governance processes for significant compliance risks.
• Evaluate recurring observations and compliance trends to identify systemic vulnerabilities requiring broader action.
• Provide compliance insights and recommendations to leadership and governance forums. Based on the Senior Director's responsibility for enterprise risk visibility and escalation.

Inspection Readiness & Health Authority Oversight

• Provide independent oversight and challenge of inspection readiness activities across assigned external manufacturing partners.
• Support readiness reviews, mock inspections, and risk-based assessments.
• Participate in regulatory inspection support activities before, during, and after inspections.
• Review regulatory commitments, remediation plans, and inspection responses for adequacy and sustainability.
• Monitor implementation of actions associated with significant inspection observations.
• Facilitate deployment of inspection learnings and best practices across the network.

External Manufacturing Compliance Oversight

• Provide independent compliance oversight of contract manufacturers, contract laboratories, external sterilization providers, critical suppliers, and strategic partners.
• Assess whether oversight approaches appropriately reflect partner risk, product complexity, regulatory history, and business criticality.
• Review compliance trends related to inspections, deviations, complaints, investigations, CAPAs, and supplier performance.
• Challenge the adequacy of risk mitigation plans and remediation strategies.
• Support compliance evaluations associated with new partnerships, technology transfers, product launches, and network changes.

CAPA Effectiveness & Recurrence Prevention

• Provide independent oversight of corrective and preventive actions arising from inspections, audits, supplier assessments, and significant quality events.
• Evaluate effectiveness verification activities and sustainability of remediation efforts.
• Assess root cause analyses for completeness and identification of systemic contributors.
• Identify repeat observations and recurring compliance issues requiring broader intervention.
• Support development of preventive actions designed to mitigate recurrence across multiple partners and products.

Governance, Regulatory Intelligence & Organizational Learning

• Support governance forums through preparation of risk assessments, trend analyses, and compliance recommendations.
• Monitor external regulatory trends, warning letters, inspection observations, and emerging expectations impacting outsourced manufacturing.
• Translate regulatory intelligence into actionable insights and compliance recommendations.
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