Job Summary：職位摘要：This position is responsible for the management of the companys Quality Assurance team and activities associated with all aspects of Quality Assurance related to systems, processes and procedures supporting the compliant introduction, manufacture & release of all products destined for ALL markets. The incumbent shall ensure (i) the Quality System complies with all relevant Regulatory requirements, (ii) our customers needs are fulfilled in a compliant manner and (iii) compliance / cost continuous improvement initiatives are successfully delivered, with appropriate education, coaching and mentoring, as necessary. 該職位負責管理公司的質量保證團隊及與質量保證系統有關的各方面相聯系的活動，支持符合引進、制造及放行所有市場的產品的流程和規程。質量主管必須確保：（一）質量體系與所有相關法規要求相符合。（二）從法規符合性的角度滿足客戶的需求。（三）必要時，通過適當的教育，培訓和指導使法規/成本不斷改進創新。 This position reports to the Quality Assurance Manager. In the absence of the QA Supervisor, the QA Manager shall assume and deliver the responsibilities outline within this PD.該職位直接向質量經理匯報。當質量主管缺席時，質量經理需履行該職位內的職責。Responsibilities / Daily Tasks: 職責/日常任務：1、Provide Technical Education, Coaching and / or Mentoring to the Quality Assurance Team and associated personnel with respect to:為小組質量人員在以下方面提供技術教育，培訓和指導：a)Regulatory compliance of all products manufactured within the TSI group to the requirements of the relevant market. 在XXX團隊內按相關市場的要求制造的所有產品的法規遵從情況。b)Regulatory compliance of all relevant Quality procedures to the requirements of relevant market. 相關市場的法規與所有質量相關的規程的符合性。c)Operational understanding of current regulatory requirements, SFDA, FDA, IMB etc. and associated regulatory guidelines.對當前相關的法規要求的理解，如SFDA，FDA，IMB及相關法規指南。d)Develop and effectively deploy an efficient training matrix for the Quality Assurance Team to appropriately support organizational requirements and personal development opportunities.制定和有效實施質量保證團隊的培訓計劃，支持組織的需求和個人發展機會。2、Perform Operational Management of the Local & Remote Site Direct reports with the Quality Assurance Team:履行本部質量保證小組和直接匯報的外地工廠質量團隊的運作管理：a)Plan, organize, manage and monitor reports to achieve short & medium term business requirements.計劃，組織，管理和監控報告，以實現短期和中期的業務需求。b)Actively participate with reports as appropriate in the Continuous Improvement initiatives aligned to organizational medium to long term goals.積極參與適當的不斷完善創新，作為有計劃性的中長期目標。c)Ensure all regulatory requirements are effectively communicated & supporting Quality System initiatives are successfully deployed locally & at all Remote Sites. 確保所有法規要求可以有效地溝通并支持質量系統成功的創新包括本部和所有外地工廠。d)Assure compliance to all relevant SFDA, FDA, IMB etc. regulatory requirements through the Quality Assurance Team, including but not limited to:通過質量保證團隊確保符合所有相關的SFDA，FDA，IMB等法規要求。其中包括但不局限于：Auditing, 審計Systems Management Review, 系統管理評審Data Trending, 數據趨勢分析Compliance Schedule Review, e.g. Validation, Stability, 符合性計劃審查，例如：驗證，穩定性e)Consistently deliver role in alignment with organizational Vision, Goals and key priorities, namely:始終如一地與團隊的長遠目標保持一致，目標和關鍵的優先事項，即：Quality, 質量Customer Service, 客戶服務Delivery Performance, 貫徹履行Cost Effectiveness, 成本效益f)Create, manage and report QA Key Performance Indicators KPIs to improve operational performance of the Quality Assurance Team:創建，管理和報告質量保證的關鍵績效指標KPIs，以改善質量保證小組的日常運作：Compliance, 合規Speed, 速度Cost, 成本People Attendance, Training etc., 人員 - 考勤，培訓等。3、Provide Senior QA input into organizational initiatives, problem solving and continuous improvement initiatives from a regulatory perspective, as necessary:從法規的角度提供高級質量保證輸入到組織計劃，解決問題和持續改進措施，必要時：a)Operational / Regulatory Issue Resolution, 行動/法規問題的解決b)Centralized Electronic Quality System, 電子質量體系c)Improved Quality Efficiency & Effectiveness, 改進質量效率和成效4、Overall Management responsibility for the administration of the Various Documentation Systems, Customer Complaints / Customer Requests / Enquiries and GMP Agreements by the QA Officers.全面負責由QA專員負責的各個文件系統，客戶投訴/客戶請求/詢問等等。5、Establish and maintain effective professional relationships with SFDA, FDA, IMB etc. regulation representatives, such as International Sponsors, Auditors etc.和SFDA, FDA, IMB等法規機構的國際主辦者、審計官員等建立并保持良好的關系。6、Perform other duties as assigned and you should be willing to perform short trips to domestic sites to assist in implementation of preventative actions / projects where required.執行其他委任的職責，應能適應在國內工廠之間短途出差以協助實施預防性措施或項目。Qualification：任職資格：1、Educational Degree：文化程度：Bachelors Degree (or above - preferred) in science / engineering or related scientific discipline with experience in operational Quality Systems in a regulated industry.在科學/工程或相關專業獲得學士學位（本科以上優先考慮），在相關行業有質量管理體系的經驗。Quality Management Certification preferred.有質量管理體系認證經驗優先考慮。2、Working Experience：工作經驗：A minimum of 5 years technical experience in quality / technical management positions in highly regulated industries; Pharmaceutical / Complementary Medicines. 至少5年在醫藥/保健藥品行業中擔任質量/技術職位工作。Management experience in the operational Quality Systems for Drug and / or Complementary Medicine products.具有藥物和/或保健藥品的質量體系的管理經驗。Sound, in-depth knowledge of the principles of GMP & GLP and other relevant regulations applicable to Therapeutic Goods destined for Local and International markets. 深刻了解GMP和GLP及其他有關的本地或國際市場的藥品法規。Demonstrated success in the Designing, Planning and Execution of quality improvement projects / programs and associated tool application and KPI reporting.有在對質量改進工程/項目方面成功設計、計劃和執行的經驗，相關工具應用和KPI報告經驗。Proven experience in Change and Risk Management associated with Drug and / or Complementary Medicine products.具有相關藥物或保健醫學產品的變更和風險評估的豐富經驗。Demonstrated skills in juggling challenging priorities, problem solving, planning, organising and decision making in highly regulated industries. 具有在高度管制的行業對復雜有挑戰性的事件解決問題、計劃、組織及決策能力。Strong analytical ability to quickly gather facts, draw conclusions associated with data and / or issues and present pragmatic solutions in a timely manner.具有高度的分析能力，能夠快速收集證據，匯同相關數據/問題給出結論并提出有實效的及時解決問題的方案。Good communication; written and verbal, and influencing / negotiation skills with internal teams, clients, and the industry regulators.良好的書面和口頭溝通技巧，良好的談判技巧