This position requires working knowledge of IT disciplines and best practices for a GxP (GCP, GLP, GMP) regulated business environment. This role is responsible for supporting compliance activities within IT audit management. The IT Quality Manager must be highly knowledgeable about the IT controls, such as various SDLC methodologies, Computer System Validation, document management, physical and logical security, disaster recovery, system deployment, etc.

This position requires to work in close collaboration within Internal IT and QA team, and also with customers from Pharmaceutical IT Function, QA, Regulatory.

主要职责:

• Responsible for internal and external audits (client, regulatory and QA), inspections, contract security reviews, client questionnaires, requests for information and proposals, and other compliance activities.
• Participate in the management and tracking resolution of IT audit findings and CAPA commitments
• Develop and maintain formal documentation related to SDLC SOPs, Computer System Validation, physical and logical security, disaster recovery and system deployment.
• Responsible for IT Supplier/Vendor/IT Self-Inspection Management program.

资历要求:

• A minimum of 3 years' experience working within an audit/compliance function, of which focused on IT Experience in an GxP regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology).
• Strong knowledge of the audit process (i.e. preparation, performance, reporting, follow-up and closure), and audit program management.
• Prior experience in heavily regulated environments such as pharmaceutical (GxPs) industries.
• Knowledgeable of regulatory compliance requirements in the pharmaceutical and drug development industry in USA and AsiaPac (GxPs) desired.
• Familiar with various validation methodologies (SDLC) and their implementation in an IT organization.
• Ability to plan, organize and execute work across multiple initiatives to drive delivery of validation commitments.
• Able to effectively prioritize tasks in a high-pressure environment.
• Strong customer service and solution-focused orientation.
• Experience working in a team-oriented, collaborative environment.
• Fluent oral and written English.
• Bachelor Degree or above, major in Computer Science or Quality Management.

上班地址：新骏环路138号1幢