Manufacturing Deputy General Manager

Job Title：Manufacturing Deputy General Manager

Location：Indonesia

Report line：General Manager of Indonesia Factory

Company introduction：

• Our client is a comprehensive pharmaceutical group based in China, integrating pharmaceutical R&D, production, and sales. The company is currently listed on both the A-share and H-share markets. It has been consistently focused on the R&D and production of innovative drugs, with its product portfolio covering multiple therapeutic areas, including gastroenterology, cardiovascular and cerebrovascular diseases, reproductive endocrinology, and neurology.

Job Responsibilities:

• Take full charge of production operations and quality management, formulate and implement product quality, production capacity delivery, and business objectives to ensure compliance with international production standards.
• Establish and optimize the quality management system in accordance with overseas market regulations (such as FDA, EMA, etc.), track international regulatory dynamics (such as ICH guidelines), and provide compliance decision-making support for management.
• Lead the development and review of documents such as quality standards, analytical methods, and batch production records, control key production process control points (such as process validation, OOS investigations), and ensure quality control across the entire chain.
• Coordinate regional quality affairs, including deviation handling, change control, supplier on-site audits, quality agreement signing, and annual quality reviews, to promote the implementation of quality improvement measures.
• Assist overseas factories in completing regulatory compliance work, including registration document preparation, declaration process follow-up, and daily compliance supervision.
• Be responsible for product release review (such as packaging material qualification, stability data), supervise post-launch transportation and storage, complaint recall, and adverse reaction investigations to ensure compliance with global quality traceability requirements.
• Organize internal self-inspections and external audits (such as customer audits, official inspections), collaborate with R&D, sales, and other departments to carry out quality training, and enhance the team's international competence.

Job Requirements:

• Master's degree or above in Pharmacy, Pharmaceutical Engineering, or related fields; over 8 years of experience in international API/formulation projects, with prior quality management experience in overseas pharmaceutical or multinational enterprises preferred.
• Familiar with international regulations such as the EU and FDA, with EMA/FDA registration, declaration, or certification experience; those with Qualified Person (QP) qualification or equivalent position experience preferred.
• Excellent English listening, speaking, reading, and writing skills, able to independently review English regulatory documents and lead cross-border conference communications.
• Strong sense of responsibility and leadership, proficient in production process optimization, cost control, and cross-departmental collaboration, with systematic problem-solving capabilities for complex issues.

Job Type: Full-time