[Hiring] Senior Manager, Clinical Supplier Quality @Insmed Incorporated

Role Description

The Senior Manager, Clinical Supplier Quality is responsible for leading and overseeing supplier quality management activities supporting global clinical suppliers across development programs. You will serve as a key supplier quality partner to cross-functional stakeholders (e.g., Clinical Operations, Clinical Development, Biometrics, Bioanalytical, etc.) and external service providers to ensure compliance with global regulatory requirements and Insmed’s quality standards. You will administer the Supplier Management Program in partnership with DevQA, supporting supplier qualification, escalation management, quality data and performance trend monitoring, and quality agreement management for clinical suppliers supporting development programs.

What You'll Do:

• Partner with DevQA to lead qualification, onboarding, risk assessment, and lifecycle management activities for clinical suppliers and service providers.
• Collaborate and lead discussions with procurement, supply chain, DevQA and cross-functional SMEs to evaluate supplier performance history, support supplier selection, and execute qualification strategies.
• Maintain and govern the approved supplier list and qualification records.
• Maintain the supplier escalation programs to ensure effective issue resolution.
• Partner with DevQA to develop, manage, and continuously improve supplier performance monitoring frameworks.
• Support supplier quality event management and continuous improvement activities.
• Analyze supplier quality data and performance trends to drive remediation actions and continuous improvement.
• Ensure supplier quality systems comply with global regulations, ICH guidelines, internal SOPs, and industry standards.
• Provide support to inspection readiness activities for suppliers.
• Support the audit program by conducting audits of suppliers.
• Own and manage the global clinical Quality Technical Agreement (QTA) program.

Qualifications

• Minimum of a Bachelor's degree in Chemistry, Engineering, Life Science or related discipline.
• Minimum of 12 years of direct experience supporting GCP regulated activities.
• Strong experience managing supplier quality programs for clinical and nonclinical outsourced service providers.
• Demonstrated experience with GCP Supplier oversight, GCP audits, Supplier qualification, CAPA management and Risk management.
• Deep understanding of ICH GCP guidelines, data integrity principles, and risk management methodologies.
• Experience working within global clinical development environments.
• Strong working knowledge of global GCP regulations and guidelines.
• Certification in GC.
• Highly proficient in data analytics, critical thinking, and decision-making concepts.

Requirements

• Act in a highly organized manner with a strong attention to detail, clarity, accuracy, and conciseness.
• Proven influencing and negotiating skillset.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support.
• 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 Learning Institute providing access to LinkedIn Learning, skill building workshops, and mentorship connections.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.

Company 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.