Our client is a biopharmaceutical companywhich develops first-in-class and best-in-class antibody products for China and the world in collaboration with international partners.

The main target is to developand manufacture clinical drug substances and drug products produced by cell culture to international standards. Facility size approx 28,000 sq. meter building and land and they are investing over RMB300M in building state-of-the art development and clinical manufacturing facilities in 2019 and will be well on the way towards obtaining the first IND approval in 2020.

新药发现，开发和生产基地

Preferred Working Style 首要的工作风格

Organized and detail-oriented advocate for quality assurance and continuous improvement.Enjoy working in highly structured system to execute changes that improve operational efficiency and product quality.

Excellent communication skills in Chinese and English to write and review bilingual documents and accurately exchange highly technical information with colleagues, auditors, clients and suppliers.

Job Functions 工作职责

Management 管理

Represent company to external parties with focus on GMP compliance and quality management.

Recruit and manage performance of Quality Assurance staff Select, approve, and manage third party contractors to provide services that supplement or complement internal capabilities; and·

Provide input into annual operating plans.

Safety and environment

Take leadership role in site safety through promotion of safe work place and personal action; and

Adhere to the Company’s safety and environmental protection procedures.

Quality Assurance

Represent the Quality Unit at audit by government Authorities and Clients.

Govern core quality assurance functions including: Quality Management System, product realization, material and supplier management, audit, Change Management, Deviation, and CAPA.

Creation and review of the Company’s Policies and procedures related compliance with Good Manufacturing Practice and support development and administration of an over-arching quality system for the company;

Create and manage the system for management of supplier quality related to medicinal products;

Responsible for obtaining and maintaining certification that the Company’s manufacturing and testing facilities comply with Good Manufacturing Practice for the intended countries of product distribution;

Approve changes, deviations, risk assessments, corrective actions, and proposed preventative actions related to product quality.

Administer the program to evaluate the effectiveness of changes;

Approve validation plans, protocols, and reports;

Responsible for the program of periodic quality reviews including regular meetings and at least annual written reports;

Responsible for processes for customer complaint and product recall;

Qualifications 任职资格

B.S. (preferably Biology or Chemistry)

Essential Experience必要经验

Minimum of 10 years responsibility in the management of quality and compliance systems for the manufacture of pharmaceutical products in China for local and international markets;

At least 6 years of operational experience in a regulated biopharmaceutical manufacturer with exposure to facility start-up;

Previous experience in writing Quality Management System documents and personal involvement in authoring of key quality documents such as: Quality Manual (QM), Policies, SOPs and forms (Document Management, Change Control, Deviation Management, CAPA, Risk Assessment, Supplier Management), training;

Expert user of Microsoft Office applications (MS Word, Excel, Outlook); and

Preferred Experience 优先考虑

Detailed knowledge of Good Manufacturing Practice of China, EU, and USA related to Quality Management Systems;

Excellent understanding of ICH Quality guidelines, including: quality of biotechnological products, pharmaceutical quality management, and quality risk management;

Previous exposure to regulatory inspections by government agencies (NMPA/CFDA, US-FDA, and EMA or similar);

Basic understanding of differences between pharmacopeia of China, USA, and EU related to biological products and critical utilities;Implementation and/or operation of electronic quality management system (eQMS);

Basic understanding of MAb development, manufacturing, and analytical process.Member of PDA, ASQ or similar.