This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

Reporting to Director, Supplier Quality the Senior Engineer, Supplier Quality will support key operational pillars of the Supplier Quality Program:

• Supplier Change Notification Program
• Supplier Qualification
• Quality Technical Agreements
• Supplier GxP Certificate Management
• Scorecard Assessments & Performance Monitoring

The scope of this role includes commercial and development (clinical) GMP.

You will be responsible for assisting in day-to-day management of the Supplier Quality Processes. You will partner with cross-functional stakeholders and external suppliers to support qualification and monitoring activities, drive regulatory compliance, reduce risk, and implement continuous improvements that strengthen supplier performance across the product lifecycle.

What You'll Do

• Partner with cross-functional SMEs and Business owners in selection, qualification, and onboarding of new suppliers.
• Lead the Supplier Change Notification program by reviewing, assessing, and coordinating Supplier Change Notifications with internal stakeholders and external suppliers.
• Assess potential impacts on product quality, compliance, and supply continuity, and ensure appropriate documentation and follow-up in the quality management system.
• Own and support lifecycle management of the global Quality Technical Agreement program to ensure alignment with internal policies and applicable regulatory requirements.
• Facilitate development, negotiation, execution, and periodic review of Quality Agreements with suppliers and Insmed SMEs.
• Monitor agreement status and effectiveness to confirm documents remain current, compliant, and aligned with business and regulatory expectations.
• Manage assignment and timely completion of Scorecards and ensure accuracy, appropriate risk allocation, and level of control are established.
• Work with the Supplier & Insmed functional SME’s to create corrective action plans to address failures in supplier’s material and services provided.
• Trend and analyze supplier performance data to identify systemic risks and improvement opportunities.
• Participate in supplier audits as required, including routine, for cause, and qualification audits.
• Ensure supplier quality documentation is complete, accurate, inspection ready, and maintained in accordance with company procedures and regulatory expectations.
• Assist with development, maintenance, and monitoring of approved supplier list, as well as maintenance of supplier files.
• Generate action items from supplier KPI’s for system enhancements and improvements.
• Assess potential suppliers for capability, quality systems, and compliance with regulatory and Insmed standards.
• Collaborate with procurement, supply chain, functional SME’s and quality assurance teams to evaluate supplier capabilities and performance history.
• Maintain supplier escalation programs to ensure that issues are getting elevated to the right levels at Insmed and within the Supplier’s organization.
• Adhere to the supplier policies and procedures, as well as global regulations and expectations (e.g. FDA, ISO, etc.) and other duties as assigned.
• Assure all supplier quality related quality documentation and records are completed thoroughly and timely to maintain compliance.
• Contribute to development and refinement of supplier quality procedures, risk assessment tools, and monitoring frameworks.

Qualifications

• Minimum of a BS degree in Chemistry, Engineering, Life Science or related discipline.
• Minimum of 8 years of relevant Quality Assurance experience of increasing levels of responsibility.
• Direct experience in supplier quality management, including qualification, auditing, and performance monitoring.
• Demonstrated experience supporting Health Authority inspections and regulatory audits.
• Thoroughly knowledgeable on Global drug cGMP's, ISO 13485, and familiar with other Regulatory Requirements.
• Direct experience with GMP compliance responsibilities, and Supplier Quality in pharmaceutical and/or medical device products.
• Experience with internal and external audits.
• Working knowledge of risk management principles and quality system processes.
• Excellent communication, negotiation, and influence skills (verbal and written).
• Highly proficient in data analytics, critical thinking, and decision-making concepts.
• ASQ CQA or similar certification, preferred.

Requirements

• Up to 10% travel based on vendor requirements.

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, 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, leadership programs, mentorship connections, and networking opportunities.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.