[Hiring] Senior Director, DSPV Quality, Training & Compliance @Insmed Incorporated

Role Description

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:

• 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.
• 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.

Qualifications

• 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.

Requirements

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

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support.
• Annual wellbeing reimbursement and access to our Employee Assistance Program (EAP).
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with a competitive company match, annual equity awards, and 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, and meaningful opportunities to connect, volunteer, and give back.