我们欢迎专注于成果、乐于学习并能带来积极能量的同事加入我们。他们需要将主动性，团队合作和协作精神完美结合。最重要的是，他们必须为我们每天服务的消费者、患者和医疗行业人士做有意义的事情而充满热情。我们致力于赋能每位员工，促进他们的个人成长，同时确保当前和未来的业务需求得到满足。在高德美，我们拥抱多样性，尊重每一位员工的尊严、隐私和个人权利。我们坚信，致力于成为世界领先的专业皮肤学公司是我们共同的雄心抱负。加入我们，您将有机会获得具有挑战性的工作经历的绝佳机会，并创造无与伦比的直接影响
Job Title: ESO Quality Assurance Manager
Location: Shanghai, China
Job Description
Ensure Galderma products meet the Company quality standards and comply with the relevant government regulations according to the product applicable classification: cGMP, GDP, ISO, ICH or any relevant regulations and guidance.
He/she will rely on regulatory, industry and technical expertise to:
61 Monitor, guide and promote Quality at ESO
61 Support Galderma Markets/distributors on products provided by ESO.
Initiates continuous improvements actions and develop business excellence approach across ESOs/API suppliers
The Job holder is responsible for the GMP/GDP activities in his scope related to Cosmetics/ Medicinal products according to but not limited to the following requirements:
61 China NMPA New Cosmetics Requirements (CSAR) and China Safety and technical Standards for Cosmetics (STSC) and relevant GB
61 ISO 22716 Cosmetics Guidelines on Good Manufacturing Practices
61 The Cosmetic Regulation (1223/2009)
61 Local GMP and regulatory requirements
61 EU- GMP Guideline Chapter 4
61 Swiss MLPO Chapter 2, Section 1-3
61 EU GDP Guideline according 2013/C 343/01
The Job holder ensures that his team works in compliance with these above-mentioned regulation
Scope
61 Galderma's ESO Oversight
61 Support to the other Galderma divisions and Market on their ESO Quality related topics.
61 Primary QA Contact for ESO
61 Technical support to comply with local regulatory requirements
61 Primary lead for Technical Quality Agreements approval and renewal
61 QA contact for communication of QA issues to the ESO
61 QA support for audits, investigations, trends, complaints, investigations, corrective and preventive actions (CAPA), validation support, and product release issues as needed
61 QA support of projects including but not limited to new product introduction, product/industrial transfers (production and analytical) for routine product, life-cycle management changes/geoexpansions
61 Provide KPI & perform Quality Review with ESO
61 Quality Management review of ESO including in the Portfolio.
61 Coordination of activities with various Galderma stakeholders such as Supplier Relationship Team, Supply Chain, Procurement, Legal, etc. to manage the relationship, manage crisis and supply issues, etc.
Duties and responsibilities
o The incumbent will define performance & regulatory compliance related goals, objectives and KPIs for ESO
o He/she will provide leadership to co-ordinate the operational quality management of ESO
o He/she will promote improvement programs and alignments in all related ESO.
o He/she will be actively involved in the resolution of critical/major quality issues (leading to supply issues) and to discrepancies found through audits, inspections, or complaints and their related investigations
o This position will accompany ESO to favor continuous improvement program and preventive actions over corrective actions
o He/she will provide support in the interpretation and application of regulatory guidelines to ensure that ESO/API Suppliers adhere to regulatory requirements and are consistent with industry standards
o He/she will provide expert interpretation and application of regulatory guidelines to ensure that ESO/API Suppliers adhere to regulatory requirements and are consistent with industry standards
o He/she will notify management of significant quality or regulatory issues that may impact product quality or regulatory compliance.
o The Job holder is responsible for the GMP/GDP activities in his scope related to medicinal products according following requirements:
o China NMPA New Cosmetics Requirements (CSAR) and China Safety and technical Standards for Cosmetics (STSC) and relevant GB
o ISO 22716 Cosmetics Guidelines on Good Manufacturing Practices
o The Cosmetic Regulation (1223/2009)
o Local GMP and regulatory requirements
o EU- GMP Guideline Chapter 4
o Swiss MLPO Chapter 2, Section 1-3
o EU GDP Guideline according 2013/C 343/01
o The Job holder ensures that his team works in compliance with these above mentioned regulation
Knowledge of different regulations:
61 ISO 22716 Cosmetics Guidelines on Good Manufacturing Practices
61 The Cosmetic Regulation (1223/2009)
61 Local GMP and regulatory requirements
61 GMP (FDA, EU, ICH, PICs regulations, cGMPs related to all major territories),
61 GDP regulatory requirements
61 Medical Device applicable regulations (NF EN ISO 13485; CMDCAS; directive 93/42/EC; 21 CFR 820, …).
o ESO/API Suppliers
o ESO SRT
o Global ESO Functional Lead
o Global & Local Supply Chain
o Global & Local Procurement
o Global & Local Regulatory Affairs
o GBU
Skills & Qualifications
61 Pharmacist or Bachelor's degree in Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology or another relevant scientific or engineering discipline; advanced degree is preferred.
61 Six Sigma / Lean Manufacturing certification is a serious plus.
61 At least 5 years of relevant experience in the pharmaceutical or biopharmaceutical industry.
61 English and Chinese fluent written and oral, other spoken languages are an asset in building connections with the functions / regions / countries.
61 MS Office (Word, Excel, Power Point).
61 eDocument Management, PATH Training, Trackwise (Deviations, Inquiries & Complaints, CAPA’s, Changes, Audits and Action plan)
61 a sound knowledge of the applicable regulations for drugs, cosmetics, medical devices.
61 a demonstrated knowledge and execution of Quality Operations
61 Capacity to negotiate and manage external partners
61 Ability to work in matrix organization (affiliates, global, ESO)
61 Communicate clearly and professionally in both writing and verbally
61 Ability to interpret and relate Quality standards for implementation
61 Flexibility and agility in problem solving, providing direction to meet business objectives are expected
61 Ability to move and adapt in a fast-changing business environment.
61 Knowledgeable in several areas of the global pharmaceutical/consumer industry, including the interpretation and practical application of applicable regulations.
61 Able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely affect activities across several departments.
加入我们:
在高德美，您有机会获得具有挑战性的全新工作经历，并直接发挥无与伦比的影响力。我们供富有创新力和责任感的工作机会，您将在各个地区、不同职位的同事的支持下开展工作，他背景多元且同心协力，他们拥有共同的工作热情。
高德美是专注皮肤学领域的全球领导者，在大约90个国家和地区开展业务。我们为世界提供创新的、以科学为基础的优质旗舰品牌和服务组合，横跨注射美学、日常护肤和皮肤治疗这三个快速增长的皮肤学细分市场。自1981年成立以来，高德美一直热忱专注于人体***的器官——皮肤，与专业医务工作者合作，以卓越成果满足消费者和患者的需求。肌肤塑造了我们的人生，由此，高德美致力于不断推进“每一个进步 为每一寸肌肤”。高德美的旗舰品牌组合包括注射美学品牌瑞蓝、吉适、Azzalure、Alluzience和Sculptra，皮肤治疗品牌Soolantra、Epiduo、达芙文、Aklief、Epsolay、Twyneo、Oracea、Metvix、班赛和罗每乐，以及日常护肤品牌丝塔芙和Alastin。