Senior Manager, Clinical Supplier Quality

Insmed; New York (NY); On-site; USD 180,000 - 230,000; Full time

Job summary

Insmed seeks a Senior Manager of Clinical Supplier Quality to lead supplier oversight and compliance across global clinical development programs. You will manage qualification, performance monitoring, quality agreements, and regulatory inspections to ensure adherence to GCP standards and quality expectations.

In this role, you will drive supplier qualification, risk assessment, and lifecycle governance while partnering with cross-functional teams to uphold data integrity and regulatory readiness

Qualifications

• Bachelor's degree required in a relevant field and 12+ years GCP-regulated experience.
• Experience leading supplier quality programs for outsourced clinical and nonclinical providers.
• Strong knowledge of ICH GCP guidelines, data integrity, and risk-based quality management.

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

Skills

GCP supplier oversight

CAPA management

Quality risk management

Data integrity principles

Audits

Regulatory inspections readiness

Negotiation

Analytical skills

Organizational skills

Education

Bachelor's degree in Chemistry, Engineering, Life Science, or related field

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