MSD Associate Director Quality Assurance 

China, Shanghai, Shanghai 

601033805

Job Description

Responsibility:

• Vaccine Local Release
• Overall 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.

Current Contingent Workers apply

Not ApplicableNot Indicated

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.