Senior Leader, External Partners Quality & Compliance

ABBVIE; North Chicago (IL); On-site; USD 125,000 - 237,000; Full time

Job summary

AbbVie is seeking a Senior Manager, External Partners Oversight, to provide leadership and direction in evaluating supplier compliance with worldwide regulatory requirements. The role ensures activities meet quality, regulatory standards, and are well-documented to safeguard medical devices, drug development materials, and related suppliers.

The position emphasizes collaboration with R&D, cross-functional project leadership, and the ongoing improvement of supplier oversight programs to mitigate

Qualifications

• Bachelor’s degree in a technical or scientific area with substantial industry experience (8+ years) in medical device or related fields.
• Strong understanding of international regulatory standards and GxP (GMP, GLP, GCP, GDP, GCLP).
• Technical background with solid supplier oversight experience.
• Excellent oral and written communication, leadership, and sound judgment.

Responsibilities

• Assess supplier oversight for regulatory compliance and early issue detection.
• Interpret and apply current governmental regulations, guidelines, and procedures.
• Manage the lifecycle of Quality Agreements and conduct cross-functional reviews.
• Provide expertise on GXP requirements within R&D and supplier quality areas.
• Collaborate with R&D to resolve external supplier quality issues.
• Lead or participate in strategic, cross-functional projects to improve compliance.

Skills

Regulatory affairs

Quality assurance

Leadership

Communication skills

Interpersonal skills

Education

Bachelor’s degree in Chemistry/Pharmacy/Biology/Engineering

Job description

AbbVie is seeking a Senior Manager, External Partners Oversight, to provide leadership and direction in evaluating supplier compliance with worldwide regulatory requirements. The role ensures activities meet quality, regulatory standards, and are well-documented to safeguard medical devices, drug development materials, and related suppliers.

The position emphasizes collaboration with R&D, cross-functional project leadership, and the ongoing improvement of supplier oversight programs to mitigate