General Manager (Pharmaceutical Manufacturing)

Job title: General Manager (Manufacturing site)

Company Introduction:

• Our client is a comprehensive pharmaceutical group based in China, integrating pharmaceutical R&D, production, and sales. They have currently established a manufacturing plant in Spain, primarily responsible for the research, development, and production of Active Pharmaceutical Ingredients (APIs).

Job Responsibilities:

• Develop production plans, optimize processes and capacity, reduce production costs, and promote lean manufacturing implementation.
• Lead GMP system establishment, ensure production compliance, head regulatory audit responses, and review compliance documents.
• Manage production, equipment, QA, and related departments; formulate evaluation criteria and coordinate technology transfer between Chinese and international teams.
• Establish EHS management systems, implement quality risk control, and handle customer complaints and deviation rectification.
• Introduce advanced technologies to enhance efficiency, and promote local adaptation of technical documents to align with global standards.
• Control production budgets, optimize procurement and equipment maintenance, and ensure cost management and equipment reliability.

Job Qualifications:

• Over 10 years of API/formulation production management experience, with at least 5 years in senior GMP factory roles; preference for expertise in cardiovascular/infectious disease API processes.
• Proficient in EU GMP and FDA cGMP, with successful regulatory audit experience; well-versed in API compliance key points.
• Strong cross-cultural team management skills; Spanish & English (good Mandarin is a plus).
• Bachelor's degree or higher in chemical/pharmaceutical disciplines; familiar with MES/SCADA and other automation systems.
• Ability to identify compliance risks promptly, lead root cause analysis for deviations, and make efficient decisions under pressure.
• Understanding of Sino-Western cultural differences; focus on cutting-edge industry technologies (technical innovation project experience is preferred).