Senior Manager, Clinical Supplier Quality

Insmed Incorporated; Bridgewater Township (NJ); Híbrido; USD 124.000 - 161.000; Jornada completa

Descripción de la vacante

Insmed Incorporated is seeking a Senior Manager, Clinical Supplier Quality for a fully remote role. You will lead supplier quality programs across global clinical development, partnering with Clinical Operations, Biometrics, and DevQA to ensure GCP compliance and data integrity.

You will manage supplier qualification, risk assessment, KPIs, and governance, while driving CAPAs, deviations, change controls, and quality agreements. Occasional travel up to 20% may be required for audits and meetings.

Formación

• Bachelor's degree in Chemistry, Engineering, Life Science or related field.
• Minimum 12 years' experience supporting GCP-regulated activities.
• GCP oversight, audits, supplier qualification, CAPA and risk management knowledge.

Responsabilidades

• Lead and oversee supplier quality management for global clinical suppliers across programs.
• Partner with cross-functional teams (Clinical Operations, Biometrics, DevQA) to ensure regulatory compliance and quality standards.
• Develop and manage qualification strategies, risk-based oversight, and lifecycle management of clinical suppliers.
• Maintain approved supplier lists, qualification records, and governance frameworks.
• Support supplier quality event management, deviations, investigations, CAPAs, and quality agreements.
• Analyze quality data, trends, and KPIs to drive remediation and continuous improvement.
• Support inspection readiness and participate in audits/inspections as needed.
• Own the global Quality Technical Agreement program and ensure clear GxP responsibilities.

Conocimientos

Supplier quality programs

GCP audits

Qualification management

CAPA management

Risk management

Data analytics

RBQM

Cross-functional collaboration

Regulatory compliance

Educación

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

Descripción del empleo

## Senior Manager, Clinical Supplier QualityApply: Remote: NJ Corporate Headquarters: Full time: Posted Today: R3821At 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, Clinical Supplier Quality is responsible for leading and overseeing supplier quality management activities supporting global clinical suppliers across development programs. You will serve as a key supplier quality partner to cross-functional stakeholders (e.g., Clinical Operations, Clinical Development, Biometrics, Bioanalytical, 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 clinical suppliers supporting 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 clinical 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’ll 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.* Maintain the 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 clinical 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 suppliers, and participating in Health Authority inspections (including FDA, EMA, MHRA, PMDA, and Health Canada).* Support the audit program by conducting audits of 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 clinical 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 as well as a minimum of 12 years of direct experience supporting GCP regulated activities.You are or also have: * Strong experience managing supplier quality programs for clinical and nonclinical outsourced service providers.* Demonstrated experience with GCP Supplier oversight, GCP audits, Supplier qualification, CAPA management and 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.* 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.* Certification in GC.* Act in a highly organized manner with a strong attention to detail, clarity, accuracy, and conciseness.* Proven influencing and negotiating skillset.* Highly proficient in data analytics, critical thinking, and decision-making concepts.**Nice to have (but not a must):*** Experience supporting GLP regulated activities. 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.* GLP auditing or clinical research.* Prior people leadership experience. .**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**Up to 20% domestic and international travel based on supplier requirements. #LI-EG1#LI-remote**Pay Range:**$124,000.00-161,000.00 Annual