Senior Director, External Manufacturing Regulatory Compliance

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Legal & Compliance

Enterprise Compliance

People Leader

Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America

The Senior Director, External Manufacturing Regulatory Compliance Oversight, provides enterprise-level regulatory compliance leadership, independent compliance oversight, risk visibility, governance support, escalation leadership, inspection-readiness oversight, and organizational learning across the Innovative Medicine External Manufacturing network. The role serves as the primary IMRC leader for External Manufacturing and provides an independent compliance perspective on significant risks, inspection readiness, supplier oversight programs, remediation strategies, emerging regulatory expectations, and external manufacturing network changes.

The Senior Director works across Quality, External Manufacturing Operations, Supply Chain, Procurement, Regulatory Affairs, Product Development, Technical Operations, MSAT, platform compliance leaders, and business leadership to help identify significant compliance risks early, strengthen decision quality, and connect local partner signals to platform and enterprise priorities. As a member of the IMRC Leadership Team, the Senior Director builds and develops a high-performing External Manufacturing compliance organization and advances a proactive, risk-based, and enterprise-connected compliance model.

Mission:
Strengthen regulatory compliance across the External Manufacturing network by providing independent enterprise oversight, increasing visibility of significant and emerging risks, enabling timely escalation and governance, challenging the sustainability of remediation, and ensuring that relevant insights and lessons travel across partners, platforms, and the broader organization.

Enterprise Compliance Leadership Advance IMRC from reactive support toward proactive enterprise compliance leadership. Promote risk anticipation, transparency, accountability, and early escalation. Maintain independent oversight while partnering effectively with accountable business and Quality functions. Connect external partner risks to product, platform, network, patient, regulatory, and supply implications. Lead through influence across a highly matrixed and globally distributed network. Strategic Influence and Decision Support Provide an independent compliance perspective on significant External Manufacturing decisions and risks.

Assess regulatory and enterprise implications of local or partner-specific issues. Advise leadership on compliance risks, potential mitigation options, and residual risk. Support alignment when compliance, patient, supply, and business considerations require cross-functional decisions. Communicate significant risks clearly, including when the message may be difficult or unpopular. Enterprise Thinking and Organizational Capability Promote consistent approaches to risk visibility, escalation, inspection readiness, and learning across the network.

Prevent isolated partner issues from becoming broader platform or enterprise vulnerabilities. Build technical depth in External Manufacturing compliance oversight, risk assessment, inspection readiness, and governance. Develop succession strength, inclusive leadership, and enterprise perspective across the team.

External Manufacturing Compliance Strategy and Enterprise Integration Develop and continuously mature the…