职责Responsibilities：

- 负责企业质量管理体系的建立、维护和持续改进，确保符合中国 GSP及总部合规要求。

Responsible for the establishment, maintenance and continuous improvement of the enterprise's quality management system to ensure compliance with Chinese GSP, and headquarters' compliance requirements.

- 担任企业质量代表，应对药监部门检查（如飞行检查），协调处理质量事故及投诉。

Serve as the enterprise's quality representative, handle inspections by drug regulatory authorities (such as unannounced inspections), and coordinate the handling of quality incidents and complaints.

- 审核药品采购、验收、储存、运输等关键环节的合规性。

Review the compliance of key links such as drug procurement, acceptance, storage and transportation.

- 领导药品年度报告、MAH 境内责任人体系等制度的执行，确保与药监部门的沟通畅通。

Lead the implementation of systems such as the annual drug report and the MAH domestic responsible person system to ensure smooth communication with drug regulatory authorities.

任职要求Qualifications:

- 药学、医学或相关专业本科及以上学历，持有中国执业药师资格证书。

Bachelor's degree or above in pharmacy, medicine or related fields, with a Chinese licensed pharmacist qualification certificate.

- 10年以上药品质量管理经验，5年以上管理岗位经验，熟悉外资药企合规体系优先。

Over 10 years of experience in drug quality management, including at least 5 years in a management position. Familiarity with the compliance system of foreign-funded pharmaceutical enterprises is preferred.

- 精通 GSP 及国际药品流通标准，具备应对审计的能力。

Proficient in GSP and international drug distribution standards, with the ability to handle audits.

- 优秀的中英文书面及口头表达能力。

Excellent written and oral communication skills in both Chinese and English.