Senior Director, DSPV Quality, Training & Compliance at Insmed in Corporate Headquarters, NJ

Job description

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Senior Director, DSPV Quality, Training & Compliance to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Global Head of DSPV, the Senior Director will be responsible for oversight of the Drug Safety and Pharmacovigilance (DSPV) quality and compliance framework, supporting the ongoing effectiveness, inspection readiness, and regulatory compliance of the PV function. Through the aggregation and evaluation of compliance information across the PV system, the role supports both the Head of Pharmacovigilance and the EU/UK QPPV in maintaining effective oversight of the PV system and driving continuous improvement. This individual will be a key member of the DSPV Leadership Team and will partner closely with Insmed Quality. What You'll Do: In this role, you’ll have the opportunity to enable the oversight of PV activities through compliance monitoring, quality event, deviation, and CAPA management, inspection readiness, audit follow-up, procedural governance, training compliance, trend analysis, and management reporting. You’ll also be responsible for: Pharmacovigilance Compliance Oversight Maintain and continuously improve the PV compliance monitoring program, providing independent monitoring and governance support to DSPV leadership and the EU/UK QPPV, and ensuring appropriate escalation of significant issues and emerging risks. Serve as the primary DSPV liaison to Quality for PV-related compliance and quality system activities, and partner with DSPV Business Process Owners to oversee vendor performance, compliance risks, quality events, and remediation. PV System Monitoring Establish and govern DSPV standards for compliance monitoring, KPIs, and quality metrics; aggregate and analyze Business Process Owner metrics; and oversee quality and compliance dashboards. Trend performance, deviations, CAPAs, audit findings, inspection observations, and other quality indicators to identify recurring issues and systemic risks and communicate insights on PV system effectiveness to DSPV leadership and governance forums. Training and Procedural Governance Own the DSPV training framework, curricula governance, competency development, and training compliance program, partnering with Business Process Owners, HR, and DSPV leadership to support capability building, professional development, and role-based learning. Oversee the lifecycle of DSPV standards, SOPs, work instructions, and controlled documents, including development, review, approval, periodic review, version control, and archival; partner with Business Process Owners to ensure procedures, training, and performance measures remain compliant, harmonized, effective, and aligned with DSPV standards. Audit and Inspection Readiness Partner with Quality to coordinate DSPV preparation and participation in regulatory inspections, audits, and due diligence assessments. Lead tracking of audit findings, inspection observations, and associated CAPA plans, and analyze outcomes to identify trends, improvement opportunities, and compliance risks. Quality Event, Deviation, and CAPA Management Partner with Quality to ensure effective management of PV-related quality events, deviations, and CAPAs, including those arising from audits and inspections. Facilitate root cause an