[Hiring] Senior Manager, GCP/GLP Supplier Quality @Insmed Incorporated

Role Description

The Senior Manager, GCP/GLP Supplier Quality is responsible for leading and overseeing supplier quality management activities supporting global GCP and GLP suppliers across nonclinical and clinical development programs. This role serves as a key supplier quality partner to cross-functional stakeholders (e.g., Clinical Operations, Clinical Development, Biometrics, Toxicology, TBAS, 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 GCP and GLP suppliers supporting nonclinical and clinical development programs.

What You'll Do

• Partner with DevQA to lead qualification, onboarding, risk assessment, and lifecycle management activities for GCP and GLP 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 Supplier escalation programs to ensure timely issue resolution.
• 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 and industry standards.
• Provide support to inspection readiness activities for GCP and GLP suppliers.
• Support the audit program by conducting audits of GCP and GLP suppliers.
• Own and manage the global GCP/GLP Quality Technical Agreement (QTA) program.

Qualifications

• Minimum of a Bachelor's degree in Chemistry, Engineering, Life Science or related discipline.
• 12 to 15 years of direct experience supporting GCP and/or GLP regulated activities.
• Strong experience managing supplier quality programs for clinical and nonclinical outsourced service providers.
• Demonstrated experience with GCP and GLP Supplier oversight, audits, qualification, Quality Agreements, 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 strongly preferred.
• Strong working knowledge of global GCP regulations and guidelines.
• Understanding of GLP regulations and laboratory compliance frameworks is a plus.
• Highly proficient in data analytics, critical thinking, and decision-making concepts.

Requirements

• Certification in GCP auditing or clinical research (nice to have but not required).

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, and caregiver support.
• Flexible work schedules with purposeful in-person collaboration.
• 401(k) plan with a competitive company match and annual equity awards.
• Participation in our Employee Stock Purchase Plan (ESPP) and company-paid life and disability insurance.
• Company Learning Institute providing access to LinkedIn Learning and skill-building workshops.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect and volunteer.

Company Description

Insmed is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. Recognized as Science magazine’s No. 1 Top Employer for five consecutive years and certified as a Great Place to Work® in the U.S., Insmed prioritizes the human experience and values every person’s contributions to meaningful progress.