Provide coordination and oversight of functional Quality & CompliancePartnering in IMTsEncourage function ownership of QualitySustain standard process for each PQS across siteConduct Regulations and AZ global QCM compliance EvaluationAgree PQS/GMP improvement prioritiesLead regulatory inspection preparationsLead and coordinate Quality key systems in place and improvement, including, but not limited,GMP trainingDocument managementQAA managementCAPA address, feedback and follow upChange controlQuality risk managementSelf-inspectionComplaint ManagementKPI data collection and reporting to globalQuality performance review and reportingContinuous improving on quality and complianceCoordinate and lead GMP inspection from external heath authoritiesCoordinate the communication with local healthy authorityCoordinate Site registration in China market.Support CMCRC for site registration and product registration in global markets. Support China RA for product registration in China market.Lead localization of global QCM to ensure comply with corporate qualityLead intelligence of external regulation, provide compliance advise when necessaryProvide support on change management of QA E-system, eg. SAP, AZDoc, OCM, IDM， GCM etc.SAP, AZDoc, OCM, IDM, GCM等

Date Posted

18-Jun-2025

Closing Date

30-Dec-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.