Senior Manager, GCP, GLP Supplier Quality

Insmed Incorporated•NJ Corporate Headquarters, NJ

7d•$124,000 - $161,000•Remote

About The Position

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.

Requirements

Minimum of a Bachelor's degree in Chemistry, Engineering, Life Science or related discipline
12 to 15 years of direct experience supporting GCP and/or GLP regulated activities.
Strong experience managing supplier quality programs for clinical and nonclinical outsourced service providers.
Demonstrated experience with GCP and GLP Supplier oversight
Demonstrated experience with GCP and GLP audits
Demonstrated experience with Supplier qualification
Demonstrated experience with Quality Agreements
Demonstrated experience with CAPA management
Demonstrated experience with Risk management
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 Haves

Certification in GCP auditing or clinical research.

Responsibilities

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.
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.

Benefits

Comprehensive medical, dental, and vision coverage
Mental health support
Annual wellbeing reimbursement
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules
401(k) plan with a competitive company match
Annual equity awards
Participation in our Employee Stock Purchase Plan (ESPP)
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
Meaningful opportunities to connect, volunteer, and give back