Senior Director, DSPV Quality, Training & Compliance

Insmed Incorporated•NJ Corporate Headquarters, NJ

32d•$222,000 - $303,000•Remote

About The Position

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.

Requirements

Bachelor’s degree in a life sciences discipline
10+ years of experience in pharmacovigilance
3+ years of experience in a quality or compliance leadership role
Demonstrated experience managing global pharmacovigilance inspections conducted by major health authorities
Deep knowledge of global PV regulations and guidelines (FDA, EMA, ICH)
Strong track record of building and leading teams in a fast-paced, dynamic environment
Experience in a small or mid-size biopharma environment

Nice To Haves

Advanced degree (MS, PharmD, PhD) strongly preferred
Experience in both clinical and commercial stage environments preferred

Responsibilities

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.
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.
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.
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.
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.
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 analysis and preventive action development and trend quality events and CAPAs to identify recurring issues and systemic process weaknesses.
Collaborate with Quality to strengthen PV compliance and inspection readiness, recommend improvements to process compliance, governance, and monitoring, and promote a culture of quality, accountability, and continuous improvement.
Partner with the EU/UK QPPV Office and Regulatory Intelligence sources to independently oversee DSPV Business Process Owners’ assessment, implementation, and effectiveness monitoring of regulatory-driven changes impacting DSPV.

Benefits

Comprehensive medical, dental, and vision coverage and mental health support
Annual wellbeing reimbursement
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match
Annual equity awards
Participation in our Employee Stock Purchase Plan (ESPP)
Company-paid life and disability insurance
Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
Employee resource groups
Service and recognition programs
Meaningful opportunities to connect, volunteer, and give back