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 analysis and preventive action development and trend quality events and CAPAs to identify recurring issues and systemic process weaknesses.

Continuous Improvement

• 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.

Who You Are:

You must have a Bachelor's degree in a life sciences discipline and 10+ years of experience in pharmacovigilance. Additionally, you have:

• 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 Have (but not required):

• Advanced degree (MS, PharmD, PhD) strongly preferred.

• Experience in both clinical and commercial stage environments preferred.

Where You'll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Travel Requirements

This position involves occasional domestic travel for face-to-face Leadership Team meetings (approximately 5-10%).

#LI-Remote
#LI-MM

Pay Range:
$222,000.00-303,000.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• 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 with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to recruitmentfraud@insmed.com.