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.

Responsibilities:
- 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- Identify and remediate gaps/outdated terms; lead re-negotiation efforts.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.

Requirements:
- 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.

Preferred:
- 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.

Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.

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