QA总监

1. Manage quality assurance oversight for all GMP activities:

管理质量保证和监督所有GMP活动。

(a) QA batch release: Be authorized to provide efficient, timely and reliable release in accordance with GMP requirements. Accept or reject produced or purchased material as necessary. Assure that only those products which have met the established standards and specifications and have been assessed to be fit for the purpose shall be released.

QA批放行：被授权按照GMP要求提供高效、及时、可靠的放行。必要时接收或拒绝生产出的或采购的物料。确保只有符合既定标准和规范，并经过评估与用途相适应的产品才会被放行。

(b) Deviation Management: ensure the effectiveness of investigation and to make decisions on the adequacy of investigations, root cause analysis and CAPA. Responsible for decision-making of all aspects of the suitability of investigations associated with facility, process, material, and analysis that may impact the safety, strength, purity, quality or identity of the material, ensuring patient safety through the appropriate disposition of product, intermediates and material.

偏差管理：确保调查的有效性，并对调查、根本原因分析和CAPA的充分性做出决定。负责决策与可能影响物料的安全性，强度，纯度，质量或特性的设施，工艺，物料和分析相关的调查适用性的各个方面，通过适当方式处置产品、中间体和物料来确保患者安全。

(c) Audit and Inspection: ensure inspection readiness of the site with respect to all self-inspection, internal and external audits within and external to the company. When required provide responses and timely follow up on relevant corrective actions and commitments as a result of the inspections.

审计和自检：确保所有自检、公司内部和外部审计的现场检查准备就绪。如有需要时，对检查结果的相关纠正措施和承诺，作出回应并及时跟进。

(d) Key QMS elements implementation: including but not limited to

质量管理体系关键要素实施:包括但不限于：

Water Monitoring, EM Management

水系统监测、EM管理，

Handling of customer complaints & AE management

处理客户投诉和AE管理，

Oversee reprocessing management for product

监督产品的返工管理

Management of the product returns and recalls

产品退货和召回的管理

Provide CMO manufacturing Quality Oversight

提供CMO生产质量监督

Maintain GMP documentation in a compliance manner, identifying trends to prevent a recurrence, assure proper corrective actions are assigned and completed and appropriate notification is made to all relevant parties

在合规的方式下，维护管理GMP文件，识别趋势以防止再次发生，确保适当的纠正措施被分配和完成，并向所有相关方发出适当的通知

Provide QA oversight to all validation and qualification activities

对所有验证和确认活动进行QA监督

Implement QRM where applicable

适用时实施QRM

Management of preparation, review and approval of standards, procedures and specifications.

标准、程序和规范的编制、审核和批准的管理。

(e) Any other tasks assigned by the leader

完成领导交办的其他任务。

1. Accountable for supervising, coaching, and developing project QA team to ensure team works effectively and efficiently.

• 负责管理、辅导和组建项目QA团队，确保团队高效有效地工作。
• (a) Identify and develop key talents of QA team;
• 识别和发展QA团队中的关键人才；
• (b) Involved in coaching program;
• 应用教练计划；
• (c) Optimize the work arrangement continuously for high efficiency;
• 持续优化工作安排，提高工作效率；
• (d) Establish and manage department performance metrics and metric review.
• 建立和管理部门绩效矩阵，定期回顾。 4.Leadership coaching effectiveness.
• 领导力教导的有效性。
• <5.SMART> goal setting and alignment to QA team members.
• 设定SMART目标，并与QA成员达成一致意见。

1. Meet quality and productivity KPIs, ensure decreased cost and increased efficiency.

满足预期的质量和生产率KPIs，确保降本增效。

1. Accountable for supervising, coaching, and developing project QA team, ensure effective and efficient way of working

• 负责管理、辅导和组建项目QA团队，确保团队高效有效地工作。
• (a) Identify and develop key talents of QA team
• 识别和发展QA团队中的关键人才
• (b) Involved in coaching program
• 应用教练计划
• (c) Optimize the work arrangement continuously for high efficiency
• 持续优化工作安排，提高工作效率
• (d) Establish and manage department performance metrics and metric review
• 建立和管理部门绩效矩阵，定期回顾。

1. Strong expertise in QMS and HA inspections, comprehensive knowledge and understanding of regulatory requirement (NMPA, USFDA and EMA etc.) .

在质量管理体系和药监官方检查方面具有丰富的经验，综合的知识以及对NMPA、USFDA和EMA等法律法规有良好的理解。

1. This position requires the individual to be able to:

• 该岗位任职要求如下：
• (a) handle multi-tasks and provide leadership to implement solutions to complex problems using the best available technology;
• 具有领导力并能进行多任务处理，用最佳方法解决问题；
• (b) assess the impact and make decisions and take accountability;
• 能评估影响、做决定并承担责任；
• (c) demonstrate active skill in challenging status, offering practical alternatives;
• 拥有有效的技巧以挑战现状，提供可行的解决方案；
• (d) demonstrate the ability to develop and promote an environment that nurture creativity and improvement of the current way of working;
• 能形成和促进具有创新和持续改进的工作氛围；
• (e) demonstrate influencing, trust-building, and change management skills;
• 具有影响力、能建立互信，以及管理变化的能力；
• (f) have good understanding on manufacturing processes and unit operation.
• 对生产工艺和操作单元具有良好的理解。

1. Lead by example.

具有模范带头作用。

1. Establish and maintain a good communication link with all internal and external customers on quality issues.

关于质量文件，在内部和外部客户间能建立并维护良好的沟通渠道。

1. Strong communication skills.

具有较强的沟通技巧。

1. Good business relationships.

能维护良好的业务关系。

1. Leading and developing managers – leading leaders.

领导并发展管理人员 – 管理管理人员。

1. Minimum 15 years of general experience in the pharmaceutical industry with direct experience in a cGMP manufacturing environment. 8 years’ experience in quality systems required with 5 years of leadership experienced with a management role

至少15年的制药行业领域中cGMP生产环境的工作经验，8年质量体系管理经验，5年的管理经验。

1. Fluent speaking, writing and reading ability for English

流利的英语口语、书写和阅读能力。

1. Six Sigma and /or Lean experience preferred

具有6-西格玛和/或精益运营经验优先