Senior Auditor, Supplier Audit – Compliance

🔥 6 minutes ago

🇨🇳 China – Remote

⏰ Full Time

🟠 Senior

🔎 Auditor

👻 Ghost score 10%

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Carry out comprehensive quality system audits of third-party service providers and manufacturers for compliance with global regulatory requirements • Interpret, explain, and apply regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies • Independently plan and conduct external supplier audits assessing systems, facilities, and processes • Provide audit observations and review corrective actions for implementation, effectiveness, and maintenance • Assist in maintaining the approved supplier list and global audit schedule • Participate in supplier management processes, including Management Review and Supplier Change Notifications • Provide guidance and training on GxP regulations and guidelines to audit team members and internal business partners • Collaborate with Inspection Management on external audits by regulatory agencies and customers • Develop, maintain, and update departmental systems, procedures, and records • Escalate issues to management as necessary • Lead cross-functional goals and resolve project team issues with minimal oversight • Participate in strategic initiatives to improve regulatory compliance • Coordinate and conduct joint audits with AbbVie Operations • Ensure audits follow the annual audit schedule • Mentor others and serve as an effective cross-functional team leader • Report to the Director RDQA External Partners Quality Audit or designee

🎯 Requirements

• Bachelor’s degree preferably in a technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) • Demonstrated strong leadership competencies • Proficient level of technical capabilities and independence • Proven track record utilizing core and technical competencies • 8+ years’ total experience, including 3+ years in a compliance or auditing role • Exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics-related industries • Thorough understanding of international GMP and device regulatory standards, including US FDA, EU, and MDR/IVDR • Quality Assurance auditing experience preferred • Pharmaceutical/device manufacturing experience preferred • Equivalent combination of education and experience may be accepted as a substitute • Accreditation by a professional body is desirable, such as ASQ Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA)

🏖️ Benefits

• Employees can work remotely • Equal opportunity employer • Commitment to operating with integrity, driving innovation, transforming lives and serving the community