Key Responsibilities:


1.Quality Oversight

Ensure all antibody and ADC DS manufacturing processes, including vial thaw, cell culture, harvest, purification, conjugation and bulk fill comply with cGMP, FDA, EMA, and other relevant regulatory guidelines.
Implement and maintain quality systems to ensure product quality and regulatory compliance.
oversee antibody and ADC DS production processes to ensure the implementation of contamination and cross contamination control strategy.
Ensure all processes and documentation meet regulatory requirements and company standards.
As key player to support client and regulatory inspections. Ensure timely and effective resolution of audit findings.
Deep involve in the process of deviation, change control and complaints in the DS area.


2.Team Leadership and People Development:

Lead and manage DS QA team, providing guidance, training, and performance evaluations.
Develop and implement training programs to enhance the skills and knowledge of the QA team, ensuring they are well-equipped to meet regulatory standards.
Foster a culture of continuous improvement and professional development.
Identify and nurture high-potential employees, providing them with opportunities for growth and advancement within the organization.


3.Cross-Functional Collaboration:

Work closely with Production, Engineering, MSAT, and other departments to ensure seamless integration of quality processes.
Provide input and support for process improvements and new product introductions.


Qualifications:

Bachelor’s degree or above in a relevant field (e.g., Biology, Chemistry, Pharmacy, Engineering) or equivalent experience.
8 years of experience in a QA, production or MSAT role within the biopharmaceutical industry. And 3 years in management role
Proven experience and knowledge in antibody and ADC DS manufactring and control.
Strong leadership and team management skills.
Decision-making and critical thinking abilities.
Ability to work effectively in a fast-paced, dynamic environment.