Senior Specialist, Supplier Quality

About the role

The Senior Supplier Quality Specialist will manage Quality Technical Agreements (QTAs) and conduct GMP audits of suppliers, contract manufacturers, and service providers.

Responsibilities

• 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, and retirement.
• Partner with Legal, Procurement, and functional SMEs 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, 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.
• Aid in the assignment, completion, and accuracy of supplier scorecards, ensuring appropriate risk allocation and level of control.

Requirements

• Minimum 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, including 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.
• Thorough knowledge 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.
• Proven ability to influence stakeholders and collaborate across functional and organizational boundaries.
• Proficient in data analytics, critical thinking, and decision-making concepts.

Qualifications

• Must be able to partner and collaborate effectively cross-functionally, at all levels of the organization.
• Frequent domestic/international travel up to 30% may be required.

Benefits

Insmed offers comprehensive medical, dental, and vision coverage and mental health support, generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration. The company also provides a 401(k) plan with a competitive company match, annual equity awards, and participation in the Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance. Employees are eligible for various employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.

Pay

$100,000.00 - $126,500.00 Annual

Schedule

This is a fully remote role. Occasional travel for team meetings or events will be expected.