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.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role:
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, and to ensure the delivery of high-quality materials and services. 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 SMEs and Business owners in the selection, qualification, and onboarding of new suppliers. You will also 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:

In this role, you'll have the opportunity to partner with cross-functional SMEs and Business owners in selection, qualification, and onboarding of new suppliers. You will also:

• 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 to define quality expectations, responsibilities, and compliance requirements.
• 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.
• Where required, 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 i.e. External deviations trending, Supplier Notifications, audit reports and observations to implement value add system enhancements.
• 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 to ensure we are addressing and solving issues quickly and completely.

Who You Are:

You have a minimum of a BS degree in Chemistry, Engineering, Life Science or related discipline as well as a minimum of 8 years of relevant Quality Assurance experience of increasing levels of responsibility.

You are or you have:

• 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 applicable to a drug product, medical device and combination product manufacturing operation.
• 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 such as deviation management, CAPA, change control, and document control.
• 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.

Travel:

Up to 10% travel based on vendor requirements

#LI-EG1

#remote

Pay Range:
$100,000.00-126,500.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• 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 with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

• A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or
• An alternative selection process by emailing Privacy@insmed.com.
• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.