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.