AbbVie

H1B Visa Sponsor Consulting Healthcare Manufacturing

AbbVie is a global pharmaceutical company focused on discovering, developing, and delivering medicines for complex health conditions. Its portfolio spans immunology, oncology, neuroscience, and aesthetics, with operations serving patients in more than 175 countries. The company’s work combines pharmaceutical research, manufacturing, and healthcare expertise, supported by substantial investment in scientific innovation and research and development. AbbVie also highlights diversity, sustainability, and patient support as part of its broader approach to improving health outcomes and community impact.

Senior Supplier Audit and Compliance Auditor

Lead supplier quality audits and regulatory compliance reviews for AbbVie’s medicines and healthcare products. Oversee external audits, corrective actions, and cross-functional GxP initiatives.

1 hour ago

China Remote Full-time Senior English Required Auditor

Description

Audit third-party service providers and manufacturers against global quality and regulatory requirements
Apply pharmaceutical, medical device, and regulated-study regulations, guidelines, policies, and procedures
Plan and conduct independent supplier audits covering systems, facilities, and processes
Document audit findings and assess corrective actions for implementation, effectiveness, and ongoing maintenance
Help maintain the approved supplier list and global audit schedule
Support supplier management activities, including Management Reviews and Supplier Change Notifications
Train and advise audit colleagues and internal partners on GxP regulations and guidance
Work with Inspection Management on audits conducted by regulators and customers
Maintain and update departmental systems, procedures, and records
Escalate issues to management when needed
Lead cross-functional objectives and resolve project team issues with limited oversight
Contribute to strategic efforts to strengthen regulatory compliance
Plan and conduct joint audits with AbbVie Operations
Keep audits aligned with the annual schedule
Mentor colleagues and lead cross-functional teams
Report to the Director of RDQA External Partners Quality Audit or their delegate

Requirements

Bachelor’s degree, preferably in a technical or scientific field such as chemistry, pharmacy, biology, microbiology, or engineering
Demonstrated leadership ability
Strong technical skills and ability to work independently
A proven record of applying core and technical competencies
At least 8 years of total experience, including 3 or more years in compliance or auditing
Experience in pharmaceuticals, medical devices, biologics and combination products, cosmetics, eye care, or aesthetics
Strong knowledge of international GMP and device regulations, including US FDA, EU, and MDR/IVDR standards
Quality assurance auditing experience preferred
Pharmaceutical or device manufacturing experience preferred
An equivalent combination of education and experience may be accepted
Professional accreditation is desirable, such as ASQ Certified Quality Manager (CQM) or Certified Quality Auditor (CQA)

Benefits

Remote work
Equal opportunity employer
Commitment to integrity, innovation, improving lives, and community service

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