Job Responsibilities

1. Participate in formulating the business development strategy for the invested pharmaceutical manufacturing company (overseas) and be responsible for developing the annual production plan. Fully oversee the process transfer and phase GMP production tasks for the invested company's CDMO business. 2. Organize and implement the production plan to ensure timely and quality product completion, and improve the invested company's production capacity and efficiency. 3. Supervise and manage the production site to ensure effective implementation of regulations and operating procedures, and ensure that all production processes comply with system requirements. 4. Lead the optimization of process workflows, energy saving, cost control, and oversee and ensure the implementation of product technology transfer risk assessment, process validation, and necessary cleaning validation. 5. Organize and coordinate resources to ensure deviations, changes, and other quality events are investigated and rectified according to established control processes. 6. Support and cooperate with internal and external audits, organize and coordinate resources for CAPA implementation. 7. Develop and supervise the implementation of personnel performance evaluation plans, provide professional training, planning, and assessment for key positions, and optimize the personnel structure. 8. Project coordination, client communication, etc.

Job Requirements

1. Bachelor’s degree or higher, with at least 5-8 years of experience in production and quality in the industrial sector. Team management experience is preferred; familiarity with API and formulation projects is a plus. 2. Solid knowledge of quality management, strong awareness of cGMP regulations and data integrity, and the ability to quickly adapt to regulatory updates. 3. Excellent organizational, communication, and coordination skills, with a strong sense of teamwork and a clear strategic vision.

Required Languages

English