Senior Supplier Audit & Compliance Lead

BioSpace; Virginia; On-site; USD 120,000 - 160,000; Full time

Job summary

AbbVie is seeking an experienced Quality Assurance Auditor to conduct comprehensive audits of third-party service providers and manufacturers for regulatory compliance. The role involves planning, executing, and leading external audits, providing actionable observations, and coordinating corrective actions.

You will train teams on GxP guidelines and collaborate with inspection groups to support regulatory audits.

Qualifications

• Bachelor's degree in a 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).
• Accreditation by ASQ or equivalent is desirable.

Responsibilities

• Carry out comprehensive quality system audits of third-party providers and manufacturers.
• Plan and conduct external supplier audits per regulations and AbbVie specs.
• Provide feedback via audit observations and track corrective actions.
• Guide and train audit teams on GxP regulations and guidelines.
• Collaborate with Inspection Management on regulatory audits and customer audits.
• Develop and maintain departmental procedures and records.

Skills

Leadership

Auditing

GxP knowledge

Regulatory compliance

Quality systems

Education

Bachelor's degree in technical or scientific field

Job description

AbbVie is seeking an experienced Quality Assurance Auditor to conduct comprehensive audits of third-party service providers and manufacturers for regulatory compliance. The role involves planning, executing, and leading external audits, providing actionable observations, and coordinating corrective actions.

You will train teams on GxP guidelines and collaborate with inspection groups to support regulatory audits.