Senior Auditor - Global Supplier Quality & Compliance

AbbVie; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

AbbVie seeks an experienced Quality Auditor to lead comprehensive audits of third-party providers and manufacturers, ensuring compliance with global regulatory requirements. The role includes guiding audit teams, coordinating with cross-functional partners, and maintaining audit programs that support new product development.

Candidates should have 8+ years in quality assurance or auditing, with strong knowledge of GMP and device regulations; ASQ certifications are valued.

Qualifications

• Bachelor’s degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering).
• 8+ years total experience, including 3+ years in compliance or auditing.
• Experience with international GMP and Device regulatory standards (US FDA, EU, MDR/IVDR).
• Quality Assurance auditing experience preferred; Pharmaceutical/Device manufacturing experience preferred.
• ASQ certification (CQM and/or CQA) desirable.

Responsibilities

• Carry out external supplier audits for compliance of systems, facilities, and processes per applicable regulations and company specs.
• Provide audit observations and review corrective actions to verify effectiveness and maintenance.
• Plan and conduct audits independently; maintain and update the audit schedule.
• Lead cross-functional teams, mentor others, and escalate issues as needed.
• Provide guidance on GxP regulations to audit teams and internal stakeholders.

Skills

Auditing

Regulatory knowledge

Leadership

Communication

Cross-functional collaboration

Education

Bachelor's degree in technical or scientific field

Job description

AbbVie seeks an experienced Quality Auditor to lead comprehensive audits of third-party providers and manufacturers, ensuring compliance with global regulatory requirements. The role includes guiding audit teams, coordinating with cross-functional partners, and maintaining audit programs that support new product development.

Candidates should have 8+ years in quality assurance or auditing, with strong knowledge of GMP and device regulations; ASQ certifications are valued.