Job Description

Insmed seeks a Senior Manager of Clinical Supplier Quality to lead supplier oversight and compliance across global clinical development programs. The role involves managing supplier qualification, performance monitoring, quality agreements, and regulatory inspections while partnering with cross-functional teams to ensure adherence to GCP standards and quality expectations.

Responsibilities

• Lead supplier qualification, onboarding, risk assessment, and lifecycle management for clinical suppliers and service providers
• Maintain approved supplier list and qualification records with risk-based controls throughout supplier lifecycle
• Administer supplier escalation programs and performance monitoring frameworks including KPIs, scorecards, and quality metrics
• Manage supplier quality events, deviations, investigations, CAPAs, and develop quality procedures and governance frameworks
• Develop and manage global Quality Technical Agreements; support audit programs and health authority inspection readiness activities

Requirements

• Bachelor's degree in Chemistry, Engineering, Life Science, or related field
• Minimum 12 years direct experience supporting GCP-regulated activities
• Strong experience managing supplier quality programs for outsourced clinical and nonclinical service providers
• Demonstrated expertise in GCP supplier oversight, audits, qualification, CAPA management, and risk management
• Deep knowledge of ICH GCP guidelines, data integrity principles, and risk-based quality management
• Working knowledge of FDA 21 CFR Parts 11, 50, 54, 56, 312, ICH E6(R3), E8(R1), and EMA/MHRA/Health Canada clinical trial requirements
• GCP certification; strong analytical, negotiation, and organizational skills

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