Senior QA Specialist - Supplier Quality

Scorpion Therapeutics; Madison (WI); On-site; USD 90,000 - 110,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Specialist, Quality Agreements to lead development, negotiation, execution, and lifecycle management of Quality Agreements with raw material suppliers, CMOs/CDMOs, contract testing labs, distributors, and other external partners. You will draft and finalize agreements in collaboration with Legal, Procurement, Regulatory, and Operations.

Responsibilities include serving as primary contact for negotiations, maintaining a master tracker, ensuring cGMP

Qualifications

• Bachelor’s degree in a scientific/technical field or equivalent experience.
• Excellent technical writing and communication; strong attention to detail.
• Ability to manage multiple priorities and stakeholders in a cross-functional, matrixed environment.

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• Identify and remediate gaps/outdated terms; lead re-negotiation efforts.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

Skills

Technical writing

Cross-functional collaboration

Managing multiple priorities

QMS/document management

Education

Bachelor’s degree in scientific/technical field

Tools

QMS platforms

Office software

Job description

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.

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