QA Compliance Senior Auditor, GCP -Central Lab Services

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world's most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you'll have the opportunity to do meaningful work, grow your career and make a real impact on people's health around the world. Together, we're improving health and improving lives.

Senior QA Compliance Auditor

Labcorp is seeking a Senior QA Compliance Auditorto join our team in Shanghai, China.

Job Responsibilities:

• Hosts and support regulatory inspections, e.g. NMPA
• Hosts and coordinate lab accreditation inpsections, including CAP, ISO 15189
• Hosts sponsor audits
• Coordinates client request for information questionnaires
• Conducts internal audits per global audit plan
• Conducts vendor and supplier audits per global audit plan
• Contributes to global QA policies and SOP review and drafting
• Provide subject matter expertise to projects internal and external customers' questions on regulation interpretation
• Delivery of training to new QA members if needed
• Participate global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization
• Supports the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements
• Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed
• Other duties as assigned by management

• Bachelor Degree in Life Science.
• 6 years or more experience as Central Lab QA/BioA QA .
• 6 years or more experience in GCP/GLP regulatory environment

• NMPA inspection support experiences
• Client audit host experiences
• Vendor audit host experiences
• Familiar with CAP and ISO 15189

• Knowledge of multiple operational areas
• Clear communication skills, including ability to provide clear feedback
• Able to clearly articulate processes to provide training
• Able to influence process improvement initiatives and offer solutions