QA Manager (IC)

Job Location(s) CN-Shanghai
Job Number
Job Category
Quality Assurance
Position Type

Job Overview

- Conducts, reports and follows up of QA audits (routine, directed, etc.), ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards
- Ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate
- Facilitates client audits (preparation, hosting, follow up) and supports regulatory inspections ensuring timely responses and effective management of issues identified to include review and approval of responses/CAPA plans and timely closure of CAPAs
- Proactively identifies and leads/supports process improvement activities / SOP revisions
- Leads and/or participates in special projects
- Represents Audit QA on project teams and other internal forums
- Trains and mentors junior QA Audit staff/ support on-boarding of new personnel
- Manages CAPAs to resolution
- Provides monthly report of activities to Sr. QA Manager/QA portfolio Manager
- Oversees timely completion of CAPAs and QIs in QMS                                                                                          
- Supports internal and external teams in creation of CAPAs
- Maintains good working knowledge of GCP and knowledge of regulatory authority requirements and inspection support
- Interacts with QA Lead Sr. Manager and above as required for quality issue case progression, issue escalations and client notifications.
- Supports QA lead Sr. Manager and above in pulling metric data, trending and tracking of QIs for client metrics.
- Hosting of external audits/inspections e.g. regulatory inspections, strategic clients
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Perform other duties, as assigned by management


- Excellent written and oral presentation skills (English and local language)
- Excellent organization and planning skills and attention to detail
- Proven interpersonal skills
- Demonstrated ability to handle multiple competing priorities
- Ability to function as a member of a global clinical QA team


- 4 years CRO/Pharmaceutical experience
- 3 years in a GXP quality role, including at least 1 year in a GCP quality role required


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