Senior Specialist, Supplier Quality

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.

Responsibilities

• 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.

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, including direct experience with Quality Agreement authoring, negotiation, and lifecycle management in biotech/pharma.

Qualifications

• 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.
• 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.
• Proficiency in data analytics, critical thinking, and decision-making concepts.

Schedule

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

Travel

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

Pay

$100,000.00–$126,500.00 Annual