Senior Manager, GCP, GLP Supplier Quality

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:

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:

In this role, you’ll have the opportunity to partner with DevQA to lead qualification, onboarding, risk assessment, and lifecycle management activities for GCP and GLP suppliers and service providers, ensuring compliance with global regulatory requirements and risk-based oversight principles, while assessing supplier capability, quality systems, and compliance against internal and external standards.  You will also:

• 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 for new and scope expansions of existing suppliers.

• Maintain and govern the approved supplier list and qualification records, ensuring appropriate risk-based controls are defined and applied throughout the supplier lifecycle in alignment with business and regulatory expectations.

• Maintenance of 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 effectively in a timely manner.

• Partner with DevQA to develop, manage, and continuously improve supplier performance monitoring frameworks for GCP and GLP suppliers in collaboration with the functional representatives, including KPIs, scorecards, and quality metrics, ensuring accurate risk-based scoring, timely completion, and appropriate control alignment.

• Support supplier quality event management and continuous improvement activities, including deviations, investigations, change controls, CAPAs, and development of supplier quality procedures, policies, templates, and governance frameworks.

• Analyze supplier quality data and performance trends, including deviations, CAPAs, audit findings, inspection outcomes, data integrity issues, and timeliness metrics, and facilitate, in collaboration with functional representative supplier governance forums and business reviews to drive remediation actions, corrective measures, and continuous improvement while maintaining accurate supplier records and approved supplier listings.

• Ensure supplier quality systems comply with global regulations, ICH guidelines, internal SOPs, and industry standards, while driving adherence to ALCOA+ data integrity principles and ICH Q9 risk management methodologies across outsourced activities.

• Provide support to inspection readiness activities for GCP and GLP suppliers,  and participating in Health Authority inspections (including FDA, EMA, MHRA, PMDA, and Health Canada).

• Support the audit program by conducting audits of GCP and GLP suppliers and providing subject matter expertise through peer review, consultation on audit findings, and input on criticality assignment, ensuring that audit outputs remain objective, evidence based, and aligned with applicable regulatory standards.

• Own and manage the global GCP/GLP Quality Technical Agreement (QTA) program, including development, negotiation, execution, maintenance, periodic review, and renewal of Quality Agreements to ensure clear definition of GxP responsibilities, quality oversight, escalation pathways, data integrity expectations, inspection support obligations, and alignment with evolving regulatory and business requirements.

Who You Are:

You have a minimum of a Bachelor's degree in Chemistry, Engineering, Life Science or related discipline along with 12 to 15 years of direct experience supporting GCP and/or GLP regulated activities.

You are or you have: 

• Strong experience managing supplier quality programs for clinical and nonclinical outsourced service providers.

• Demonstrated experience with:

  • GCP and GLP Supplier oversight

  • GCP and GLP audits

  • Supplier qualification

  • Quality Agreements

  • CAPA management

  • Risk management

• Quality Fundamentals: Deep understanding of ICH GCP guidelines, data integrity principles, and risk management methodologies (e.g., RBQM).

• Experience working within global clinical development environments strongly preferred.

• Strong working knowledge of global GCP regulations and guidelines, including FDA 21 CFR Parts 11, 50, 54, 56, and 312, ICH E6(R3), ICH E8(R1), EU Clinical Trials Regulation (EU) No. 536/2014, EU Annex 11, MHRA GCP guidance, EMA inspection expectations, and Health Canada clinical trial requirements.

• Understanding of GLP regulations and laboratory compliance frameworks, including FDA 21 CFR Part 58, OECD Principles of GLP, EPA GLP requirements (where applicable), WHO GLP guidance, and data integrity and computerized systems expectations in laboratory environments is a plus.

• Highly proficient in data analytics, critical thinking, and decision-making concepts.

Nice to have (but not required):  

• Certification in GCP auditing or clinical research.

Where You’ll Work  

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Travel Requirements  

This position involves frequent domestic/international travel up to 20% based on supplier requirements.

Pay Range:

$124,000.00-161,000.00 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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

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.

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 [email protected]  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.