Quality Leader

Job Description SummaryThe role ensures that all distributors meet GDP activities comply with regulatory requirements and company standards. The Manager oversees day-to-day quality operations, including deviations, investigations, CAPAs, change controls, and internal and external audits. This position also manages vendor oversight and audit closure, supports SOP development and control, maintains personnel training programs and records, and oversees QA documentation and archival processes.
Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

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Job Description

Key responsibilities/ 主要职责

药品经营质量负责人全面负责放射性药品经营质量管理工作，独立履行职责，在企业内部对放射性药品质量管理具有裁决权，督促企业相关部门有效履行《药品经营质量管理规范》规定的职责。

贯彻、执行有关放射性药品经营质量管理的法律、法规和行政规章；

统筹安排公司质量管理相关工作，并指导、落实，规范公司的经营活动，使公司的经营管理合规、科学。

参与公司质量方针和总体质量目标的制订。对各部门分解的质量目标进行审核并监督实施。

主持公司质量管理体系的建设，协助企业负责人完善公司质量管理体系。对质量管理体系文件进行审核、审批。

组织质量管理体系内审活动，推进质量管理体系有效运行，组织实施质量改进措施，并报告质量管理体系的运行情况。

参加质量评审会议，评估质量管理体系运行情况和质量风险

负责首营企业和首营品种及客户资质的审批；

负责验证工作的监督、指导、审批；审批验证方案和报告

负责可疑放射性药品和不合格品处理审核、审批。

指导质量事故的调查和处理，并对质量事故报告进行审核。

听取质量管理部关于质量工作情况的汇报，并对有关质量问题给出处理意见。

Education and qualification requirement/ 教育和资质要求

药品经营质量负责人应当符合《中华人民共和国药品管理法》及《药品经营质量管理规范》等有关法律、法规、规章和有关文件规定的资格要求，不得有相关法律法规禁止从业的情形。

药品经营质量负责人由高层管理人员担任

具有核医学、药学、临床医学或放射性化学相关专业大学本科以上学历和执业药师资格，以及3年以上药品经营（批发、连锁总部）质量管理工作经历，在质量管理工作中具备正确判断和保障实施的能力；

熟悉《药品管理法》《放射性药品管理办法》等法律法规的要求，熟悉放射性药品知识和辐射防护知识

Take full responsibility for the quality management of radiopharmaceutical operations, independently fulfil his/her responsibilities, and has independent authority and decision power over the quality management of radiopharmaceuticals within the enterprise.

Ensure compliance with the Good Supply Practice (GSP) for pharmaceuticals and relevant laws, regulations, and administrative rules.

Oversee and guide company-wide quality management activities, ensuring business operations are compliant, standardized, and scientifically sound.

Participate in the development of the company’s quality policy and overall quality objectives; review departmental quality targets and monitor implementation.

Lead the establishment and continuous improvement of the company’s quality management system; review and approve system documentation.

Organize internal audits, drive effective operation of the quality management system, implement corrective actions, and report on system performance.

Attend quality review meetings to assess system performance and evaluate quality risks.

Approve qualifications of new suppliers, new products, and new customers.

Supervise, guide, and approve validation activities, including validation protocols and reports.

Review and approve handling of suspected radiopharmaceuticals and non-conforming products.

Guide investigations and resolution of quality accidents; review quality accident reports.

Receive reports from the Quality Management Department and provide decisions on quality-related issues.

Education & Qualification Requirements

Shall comply with the qualification requirements specified in the Drug Administration Law of the People’s Republic of China and Good Supply Practice (GSP) and other relevant laws and regulations, and shall be under no Job Forbidden by relevant laws and regulations.

Should be a senior management-level position.

Bachelor’s degree or above in Nuclear Medicine, Pharmacy, Clinical Medicine, or Radiochemistry, and qualification certificate of licensed pharmacist, working experiences in quality management of drug distribution (wholesale or chain headquarters) for more than 3 years with proven ability to make sound judgments and ensure execution.

Familiarity with the Drug Administration Law of the People’s Republic of China, Radiopharmaceutical Management Measures, and related regulations. Knowledge of radiopharmaceuticals and radiation protection principles.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.