Senior QA Specialist - Supplier Quality Agreements
$90,000–$110,000 year
On-siteVerona, Wisconsin, United States
Job Summary
Draft, review, and finalize Quality Agreements with raw material suppliers, CMOs, contract testing laboratories, and distributors, ensuring clear delineation of roles for batch release, deviations, change control, and audit rights. Maintain the master Quality Agreement tracker, manage renewal dates and amendments, and integrate terms into the supplier qualification and annual review lifecycle. Collaborate with Legal, Procurement, and Regulatory Affairs to coordinate cross-functional approvals, drive negotiations to closure, and lead remediation of outdated terms. Support internal and external audits by providing documentation and responding to findings, while tracking metrics for leadership. Contribute to continuous improvement of Quality Agreement templates and QMS procedures.
Required Qualifications
- 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
- Candidates must have current, valid authorization to work in the country where this role is located
Desired Qualifications
- 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
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