Senior Specialist, 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 What You'll Do: Role In this role,you’llhave the opportunity tolead the drafting, review, and negotiation of QTAs with suppliers, contract manufacturers, and service providers, driving timely resolution of supplier comments and redlines. You’llalso: Quality Technical Agreement (QTA) Management Own the end-to-end lifecycle management of QTAs, including initial execution, periodic review, renewal, revision, and retirement, in accordance with company procedures and regulatory expectations. Partner with Legal, Procurement, and functional SMEs (e.g., Manufacturing, Regulatory Affairs, Quality Control) to ensure QTA content accurately reflects roles, responsibilities, and regulatory requirements between the company and its suppliers. Maintain a current inventory/tracker of all QTAs, including status, expiration/review dates, and outstanding action items. Identify gaps or conflicts between QTA terms and actual practice, and drive resolution with internal and external stakeholders. External Supplier GMP Audits Conduct GMP audits of suppliers, contract manufacturers, and service providers, including routine, for-cause, and qualification audits. Independently lead audits as Lead Auditor, including opening/closing meetings, evidence gathering, and drafting clear, well-supported audit reports. Evaluate supplier corrective action responses for adequacy, effectiveness, and timeliness; follow up to ensure timely closure. Support Health Authority inspections and internal/external regulatory audits as a supplier quality subject matter expert. Supplier Quality Support Support supplier qualification and requalification activities, including risk assessments, questionnaires, and approval of new and existing suppliers. Track and maintain supplier GMP certificates (e.g., cGMP, ISO 13485) and other regulatory/quality documentation to ensure currency and inspection readiness. Assist with the assignment, completion, and accuracy of supplier scorecards, ensuring appropriate risk allocation and level of control. Who You Are You have aminimumof a Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related discipline along 10 to 12 years of relevant Quality Assurance/Supplier Quality experience of increasing responsibility, including direct experience with Quality Agreement authoring, negotiation, and lifecycle management in biotech/pharma. You Are Or You Have Direct experience leading GMP audits of suppliers, contract manufacturers, and/or service providers, including routine, for-cause, and qualification audits. Direct experience in supplier quality management, including supplier qualification, risk management, and performance monitoring (e.g., scorecards, KPI trending). Experience supporting Health Authority inspections and regulatory audits. Must be thoroughly knowledgeable of global drug cGMPs, ISO 13485, and other regulatory requirements applicable to drug product, medical device, and combination product manufacturing operations. Working knowledge of quality system processes such as deviation management, CAPA, change control, and document control. ASQ Certified Quality Auditor (CQA) certification or similar preferred. Strong negotiation, written, and verbal communication skills, with demonstrated ability to drive comment resolution and alignment with external …

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