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.

What You'll Do:

In this role, you'll have the opportunity to lead the drafting, review, and negotiation of QTAs with suppliers, contract manufacturers, and service providers, driving timely resolution of supplier comments and redlines. You'll also:

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 a minimum of 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 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.

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 30%.

Pay Range:
$100,000.00-126,500.00 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.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.