Remote Quality Management System Jobs in Fort Atkinson, WI

The Position

The Senior Specialist, Quality Agreements is a member of the Supplier Quality team and is responsible for the development, negotiation, execution, and lifecycle management of Quality Agreements (i.e. QTAs, QAAs, etc.) with raw material suppliers, contract manufacturing organizations (CMOs/CDMOs), contract testing laboratories, distributors, and other external partners in the pharmaceutical supply chain supporting clinical and commercial programs at Arrowhead Pharmaceuticals.

This role ensures that quality and compliance responsibilities are clearly defined, aligned with applicable regulatory requirements (FDA, EMA, ICH, ISO), and fully integrated with the broader Supplier Quality Management program — including supplier qualification, risk classification, performance monitoring, and periodic review. The ideal candidate combines strong technical writing skills, GMP/regulatory knowledge, and cross-functional collaboration experience to ensure every supplier and partner relationship has clear, current, and enforceable quality terms.

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 escalate 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.

Requirements

• Bachelor's degree in a scientific, technical, or related field (e.g., Life Sciences, Chemistry, Pharmacy, Engineering) or equivalent experience
• 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.
• Proficiency with document management/QMS platforms and standard office software.

Preferred

• Direct experience as part of a Supplier Quality or Vendor Management team, including supplier audits or assessments.
• Familiarity with API, excipient, or component supplier quality requirements.
• Strong negotiation and stakeholder-management skills
• Organized, with strong follow-through on deadlines and deliverables
• Excellent interpersonal, verbal, and written communication skills.
• Ability to consistently communicate with external parties in a professional manner.
• Ability to work independently with minimal supervision as well as manage priorities within a face paced environment.