[Hiring] Senior Specialist, Supplier Quality @Insmed Incorporated

Role Description

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

• Lead the drafting, review, and negotiation of QTAs with suppliers, contract manufacturers, and service providers.
• Own the end-to-end lifecycle management of QTAs, including:
  • Initial execution
  • Periodic review
  • Renewal
  • Revision
  • Retirement
• 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.
• 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 audits
  • For-cause audits
  • Qualification audits
• Independently lead audits as Lead Auditor, including:
  • Opening/closing meetings
  • Evidence gathering
  • 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
  • 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.

Qualifications

• 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.
• Direct experience in supplier quality management, including supplier qualification, risk management, and performance monitoring.
• Experience supporting Health Authority inspections and regulatory audits.
• Thorough knowledge of global drug cGMPs, ISO 13485, and other regulatory requirements.
• 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.
• Ability 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.

Benefits

• 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, and caregiver support.
• 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).
• 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.

Travel Requirements

This position involves frequent domestic/international travel up to 30%.

Pay Range

$100,000.00-126,500.00 Annual