Senior Specialist, Supplier Quality
About The Position
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 Supplier Quality Specialist will be responsible for the lifecycle management of Quality Technical Agreements (QTAs) with suppliers, contract manufacturers, and service providers, and for leading and executing GMP audits of external suppliers as primary responsibility with additional support of core supplier quality activities such as supplier qualification, GMP certificate management, and supplier scorecards as assigned. The ideal candidate has a strong working knowledge across the supplier quality programs such as supplier qualification, supplier risk management, external supplier audits, and supplier notifications, and brings sound judgment, negotiation skill, and cross-functional collaboration to ensure suppliers consistently meet company and regulatory quality expectations.
Requirements
- Minimum of a Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related discipline.
- 10 to 12 years of relevant Quality Assurance/Supplier Quality experience of increasing responsibility.
- Direct experience with Quality Agreement authoring, negotiation, and lifecycle management in biotech/pharma.
- 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.
- 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.
- Strong negotiation, written, and verbal communication skills, with demonstrated ability to drive comment resolution and alignment with external suppliers and internal stakeholders.
- Must be able to partner and collaborate effectively cross-functionally, at all levels of the organization.
- Proven ability to influence stakeholders and collaborate across functional and organizational boundaries.
- Proficient in data analytics, critical thinking, and decision-making concepts.
Nice To Haves
- ASQ Certified Quality Auditor (CQA) certification or similar preferred.
Responsibilities
- 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.
- 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.
- 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.
Benefits
- Comprehensive medical, dental, and vision coverage and 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 with purposeful in-person collaboration
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
