Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Position Introduction:

Join our exceptional team as a Manager, Quality and take on a unique opportunity for skilled and experineced quality management. In this role, you will be responsible for ensuring overall quality management for 3 significant divisions. Include below key responsibilities.

Responsibilities:

• Maintain an efficient quality system to meet the requirements of regulations and customer needs, ensuring the renewal of quality certificates such as ISO 9001 and GSP license.
• Lead customer audits of Thermo Fisher and coordinate the customer audits to manufacturers.
• Lead the timely completion of quality agreements and questionnaires.
• Handle customer complaints, AE, recall, PRER, and ensure regulatory compliance.
• Manage quality operation activities, including product quality judgment and return evaluation, derogation approval, as well as related 3PL quality management.
• Lead the quality management of computerized system validation and cold-chain validation.
• Indirect supplier quality management, including supplier quality evaluation and quality audits.
• Support business projects as a quality BP to deliver professional quality responses and ideas

• Bachelor's degree or above in Medicine, Pharmacy, Bioengineering, or a related field (MD preferred).
• More than 8 years of experience in quality-related functions.
• Knowledge of regulations pertaining to quality management.
• Over 5 years of experience in people management.
• workable English.

• Demonstrated experience in collaborating across different departments and working with various individuals or groups involved.
• Excellent communication and driven skills.
• Demonstrated proficiency in effective problem-solving and decision-making, along with strong analytical skills and a focus on data-driven approaches.

• This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes will not receive a response.