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Job Title: Biologics QA Director

Job Location: Chengdu, China

Job Type: Full-time

Job Description:

1. Responsible for building of QA team of biologics (including therapeutic monoclonal antibodies, bispecific antibodies, ADC, fusion protein, etc.), and for the daily management of QA teamï¼›

2. Responsible for establishing, maintaining and continuously improving the quality assurance system to ensure that the company's quality system functions efficiently;

3. Responsible for organizing and implementing the company's internal quality management system including self-testing, regular auditing and assessing of applicability and effectiveness of the quality management system, and for organizing various types of company GMP certification (domestic and international);

4. Responsible for coordinating quality audit by the third-party audit department and customers (e.g. entrusting party);

5. To assess and audit material suppliers, and to establish and maintain a list of qualified suppliers;

6. To assist in the design and construction of new plant and production lines, and ensure that plant facilities and equipment comply with GMP regulations;

7. To organizing and coordinating validation and verification;

8. To establish the company's management system for quality control, to guide the staff to prepare the quality management system documents, to ensure that the documents through necessary approvals, and take effective measures to ensure that the system documents be implemented strictly and effectively;

9. Responsible for organizing quality-related training and taking appropriate measures to ensure training effectiveness;

10.      Responsible for deviation, change, CAPA assessment and review;

11.      To assist VP in the investigation and handling of quality complaints;

12.      Responsible for product quality review analysis, organizing to provide annual quality review analysis report.

Job Requirements:

1. Education: Bachelor degree or above (Master or above is preferred) is required in Pharmacy, bioengineering, pharmaceutical engineering, biochemistry or related fields;

2. Language: Capable of communication in English or Mandarin Chinese;

3. Experience:

(1) At least 5 years experience in quality management of biopharmaceutical products;

(2) Experience in Workshop construction, production site verification, GMP certification (US or EU certification);

(3) Experience in organizing a team to build a quality management system or quality assurance system;

(4) Experience in Quality Management (VP) in Europe and the United States is preferred;

4. Qualifications:

(1) Familiar with the drug administration laws and regulations, and GMP regulations (domestic and international);

(2) Strong forward-looking and predictability, able to plan ahead of the potential risk, and prepare effective and reasonable work plan to the more complex team;

(3) Able to think clearly and sensibly, good at analytical and problem solving skills;