Senior Auditor, Supplier Audit – Compliance

This is a fully remote position, open to applicants in China.

📋 Description

• Conduct thorough quality system audits of third-party service providers and manufacturers to ensure compliance with global regulatory standards.

• Interpret, clarify, and apply regulations, guidelines, policies, and procedures pertinent to pharmaceutical products, medical devices, and regulated studies.

• Independently organize and execute external supplier audits, evaluating systems, facilities, and processes.

• Provide audit findings and review corrective actions for implementation, effectiveness, and ongoing maintenance.

• Aid in sustaining the approved supplier list and the global audit schedule.

• Engage in supplier management activities, including Management Review and Supplier Change Notifications.

• Offer guidance and training on GxP regulations and guidelines to audit team members and internal business associates.

• Collaborate with Inspection Management on external audits conducted by regulatory authorities and customers.

• Develop, maintain, and update departmental systems, procedures, and documentation.

• Escalate issues to management when necessary.

• Lead cross-functional objectives and resolve project team challenges with minimal oversight.

• Participate in strategic initiatives aimed at enhancing regulatory compliance.

• Coordinate and conduct joint audits in partnership with AbbVie Operations.

• Ensure audits adhere to the annual audit schedule.

• Mentor colleagues and act as an effective leader within cross-functional teams.

• Report directly to the Director of RDQA External Partners Quality Audit or their designee.

⛳️ Requirements

• Bachelor’s degree, preferably in a technical or scientific field (Chemistry, Pharmacy, Biology, Microbiology, or Engineering).

• Proven strong leadership skills.

• Proficient level of technical abilities and independence.

• Established track record of utilizing core and technical competencies.

• 8+ years of overall experience, including at least 3 years in a compliance or auditing role.

• Familiarity with pharmaceutical, medical device, biologics, combination products, cosmetics, eye care, or aesthetics-related industries.

• Comprehensive understanding of international GMP and device regulatory standards, including US FDA, EU, and MDR/IVDR.

• Quality Assurance auditing experience is preferred.

• Experience in pharmaceutical/device manufacturing is preferred.

• An equivalent combination of education and experience may be considered acceptable as a substitute.

• Accreditation from a professional organization is desirable, such as ASQ Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA).

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• We are committed to operating with integrity, fostering innovation, transforming lives, and serving our community.