Senior QA Specialist - Supplier Quality

The Senior Specialist, Quality Agreements is a member of the Supplier Quality team responsible for the development, negotiation, execution, and lifecycle management of Quality Agreements (e.g., QTAs, QAAs) with raw material suppliers, CMOs/CDMOs, contract testing laboratories, distributors, and other external partners.

• Draft, review, revise, and finalize Quality Agreements with GMP-relevant external partners in collaboration with Legal, Procurement, Regulatory Affairs, and Operations.
• Serve as primary point of contact for Quality Agreement negotiations; ensure clear delineation of roles (e.g., batch/lot release, deviation/CAPA ownership, change control notification, complaint handling, audit/inspection rights, sub-tier oversight).
• Maintain master Quality Agreement tracker/inventory (renewal dates, amendments, expiration alerts, linkage to supplier risk tier).
• Ensure agreements align with cGMP, global regulatory requirements, and internal policies/SOPs.
• Integrate agreement requirements into Supplier Quality Management (supplier qualification, risk classification, periodic/annual review, scorecards).
• Coordinate reviews/approvals, drive to closure, and escalate stalled negotiations.
• Identify and remediate gaps/outdated terms; lead re-negotiation efforts.
• Support audits/inspections with documentation and responses.
• Track/report agreement metrics; contribute to continuous improvement of templates/workflows/QMS procedures.
• Assist with QA duties as needed.

• Bachelor’s degree in a scientific/technical field or equivalent experience.
• 8+ years pharmaceutical/biotechnology quality assurance, including 4+ years in supplier quality.
• Experience drafting and/or negotiating Quality Agreements.
• Solid cGMP and global regulatory knowledge (FDA 21 CFR 210/211, EU GMP Annex 16, ICH Q7/Q9/Q10).
• Excellent technical writing and communication; strong attention to detail.
• Ability to manage multiple priorities/stakeholders in a cross-functional, matrixed environment.
• Proficiency with document/QMS platforms and standard office software.

• Supplier Quality/Vendor Management experience (audits/assessments).
• Familiarity with API/excipient/component supplier quality requirements.
• Strong negotiation and stakeholder-management; organized with deadline follow-through.
• Professional communication with external parties; ability to work independently in a fast-paced environment.

Pay (Wisconsin): $90,000 USD - $110,000 USD.