Senior Manager, Supplier Quality & Regulatory

AbbVie; Illinois; On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie is seeking an experienced compliance leader to oversee supplier quality and regulatory alignment for medical devices, clinical materials, and drug development suppliers. The role emphasizes early issue detection, cross-functional collaboration, and lifecycle management of Quality Agreements.

The ideal candidate brings 8+ years in QA/Regulatory affairs with strong GxP knowledge, excellent communication, and a proven ability to drive corrective actions across RDQA teams and external

Qualifications

• Thorough understanding of international regulatory standards (GxP, GMP/GLP/GCP) and medical device regulations.
• Strong leadership, communication, and cross-functional collaboration skills.
• Experience with supplier quality oversight and quality agreement lifecycle management.

Responsibilities

• Lead supplier compliance oversight to detect issues early and drive corrective actions.
• Interpret and apply current regulations, guidelines, and procedures across R&D and external suppliers.
• Manage Quality Agreement lifecycles, including creation, reviews, and terminations as needed.
• Provide expert guidance on GXP requirements within R&D and with external partners.
• Collaborate with R&D to resolve external supplier quality issues and ensure study/program objectives are met.
• Oversee cross-functional projects and strategic initiatives to improve regulatory compliance.
• Collect, analyze, and report External Partners Quality metrics.
• Demonstrate AbbVie leadership and learning culture in daily work.

Skills

Regulatory compliance

Leadership

GxP knowledge

Quality systems

Communication

Cross-functional collaboration

Project management

Auditing

Risk assessment

Education

Bachelor’s Degree in technical or scientific field

Job description

AbbVie is seeking an experienced compliance leader to oversee supplier quality and regulatory alignment for medical devices, clinical materials, and drug development suppliers. The role emphasizes early issue detection, cross-functional collaboration, and lifecycle management of Quality Agreements.

The ideal candidate brings 8+ years in QA/Regulatory affairs with strong GxP knowledge, excellent communication, and a proven ability to drive corrective actions across RDQA teams and external