Associate Director, Quality Assurance

Job DescriptionResponsibility:Vaccine Local ReleaseOverall manage the vaccine release-related activities in China.Ensure the local vaccine products batch release protocols and associated documents for batch release application to NIFDC are well prepared and on time submitted.As the key contact point of NIFDC, develop and maintain good relationships and address their inquiries related to batch release documents in a timely manner by working with our company's local and global teams.Coordinate annual product reviews for Vaccine products.Coordinate product quality issues handling when needed.Requirements:BS or above degree in the relevant area.At least 10 years of experience in QA, QC, or the manufacturing department of a pharmaceutical company; vaccine or biologics manufacturing experiences preferred.Experience in interactions with various Health Authorities, e.g. CFDI and NIFDC.Good understanding of China regulations on Vaccine/Biologics products and other drug products.Expert in GMP activities, familiar with QMS processes, especially for Deviation, CAPA, and Change Control management.Demonstrates leadership through problem-solving, project management, or team management.Advanced ability to work with different partners to accomplish quality goals.Good skills in decision-making: utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.Good Mandarin and English communication skills in speaking and writing.Employee Status:

RegularRelocation:

DomesticVISA Sponsorship:

NoTravel Requirements:

25%Shift:

Not IndicatedValid Driving License:

NoHazardous Material(s):

n/aJob Posting End Date:

01/1/2025Requisition ID:

R315887

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