Senior Supplier Quality Agreements Lead

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI, is seeking a Senior Specialist, Quality Agreements to lead the development, negotiation, execution, and lifecycle management of Quality Agreements with raw material suppliers, CMOs/CDMOs, and contract testing labs, supporting clinical and commercial programs.

The role ensures terms align with cGMP and global regulations, integrates with the Supplier Quality Management program, and collaborates across Legal, Procurement, Regulatory Affairs, and

Qualifications

• Bachelor's degree in a scientific, technical, or related field.
• Minimum of 8 years of quality assurance experience in a pharmaceutical or biotechnology quality, with 4+ years in supplier quality.
• Demonstrated experience drafting and/or negotiating Quality Agreements with suppliers, CMOs/CDMOs, or contract testing laboratories.
• Solid working knowledge of cGMP requirements and global regulatory frameworks (FDA 21 CFR Parts 210/211, EU GMP Annex 16, ICH Q7/Q9/Q10).
• Excellent written and verbal communication skills, with strong attention to detail and technical writing ability.
• Proven ability to manage multiple priorities and stakeholders in a cross-functional, matrixed environment.

Responsibilities

• Draft, review, revise, and finalize Quality Agreements with raw material suppliers, CMOs/CDMOs, contract testing laboratories, distributors, and other GMP-relevant external partners, in collaboration with Legal, Procurement, Regulatory Affairs, and Operations.
• Serve as the Supplier Quality team's primary point of contact for Quality Agreement negotiations, ensuring roles and responsibilities are clearly delineated (e.g., batch/lot release, deviation and CAPA ownership, change control notification, complaint handling, audit and inspection rights, sub-tier supplier oversight).
• Own and maintain the master Quality Agreement tracker/inventory within the Supplier Quality program, including renewal dates, amendments, expiration alerts, and linkage to supplier risk tier.
• Ensure Quality Agreements align with current Good Manufacturing Practice (cGMP), applicable global regulatory requirements, and internal quality policies/SOPs.
• Integrate Quality Agreement requirements into the full Supplier Quality Management lifecycle, including new supplier qualification, risk classification, periodic/annual supplier review, and supplier scorecards.
• Collaborate with Supplier Quality team members to ensure Quality Agreement terms are reflected in supplier audit scope and are verified during on-site or remote assessments.
• Coordinate cross-functional review and approval workflows, drive agreements to closure within established timelines and elevation of stalled negotiations as needed.
• Identify gaps, inconsistencies, or outdated terms in existing agreements (e.g., following organizational, regulatory, or product changes) and lead remediation and re-negotiation efforts.
• Support internal and external audits and regulatory inspections by providing Quality Agreement documentation and responding to related findings or observations.
• Track and report Supplier Quality Agreement metrics to Supplier Quality leadership.
• Contribute to continuous improvement of Quality Agreement templates, workflows, and the associated Supplier Quality Management System (QMS) procedures, as well as overall QMS programs and procedures.
• Assist with QA duties as needed.

Skills

Quality writing

GMP knowledge

Cross-functional collaboration

Attention to detail

Project management

Education

Bachelor's degree in Life Sciences or related field

Tools

QMS software

MS Office

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI, is seeking a Senior Specialist, Quality Agreements to lead the development, negotiation, execution, and lifecycle management of Quality Agreements with raw material suppliers, CMOs/CDMOs, and contract testing labs, supporting clinical and commercial programs.

The role ensures terms align with cGMP and global regulations, integrates with the Supplier Quality Management program, and collaborates across Legal, Procurement, Regulatory Affairs, and