Quality Manager
Sanofi.com
Office
Shanghai, China
Full Time
Job title: Quality Manager
- Location: Shanghai
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.
At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.
Mission & Tasks
Commercial Quality Compliance商业质量合规
GSP Compliance 药品经营质量管理规范合规
Audit and Inspection 审计与检查
Scope of Responsibility
Management Responsibilities :
Commercial Quality 商业质量合规：
- Implement and support consumer/OTC sector quality system related to deliver R&R; 贯彻和支持相关的消费者药业/非处方药的质量体系；
- Collaborate with relevant partner to ensure compliance of consumer/OTC sector the Global Guidelines and Policies including enterprise standards related to Quality and Regulatory Compliance for Deliver. 与业务伙伴合作， 确保有关消费品/OTC 的质量和法规符合全球指南与公司标准的要求 ；
- Coordinate consumer/OTC DCs on the compliance to Sanofi/Opella enterprise standard including supplier management, Repack/Relabel, Temperature Control, Product Return, Distribution Complaints, etc. 与消费品/OTC相关的DC协作， 包括供应商管理，贴标/再包装， 温度控制，产品退货，配送投诉等流程，确保符合全球公司要求；
- Ensure compliance of GDP requirements for consumer/OTC DCs 确保与消费品/OTC相关的DC符合GDP的要求；
- Deploy supplier qualification, audit, monitor and lifecycle for Consumer/OTC DCs 贯彻消费品/OTC 相关确认，审计，监控与全生命周期管理；
- Work with cross function team through new product development to identify risks associated with quality and regulation compliance and develop actions to mitigate the risks to ensure on time launch. Contribute to the NPD/ NPI process and support business in driving compliant growth. 通过新产品开发与跨职能团队合作，识别与质量和法规合规相关的风险，并制定行动来降低风险，以确保成功上市，为 NPD/NPI 流程做出贡献，并支持业务、并推动合规增长；
- Lead to solve business quality related issues through end-to-end product life cycle. Initiate and coordinate CAPA to address and ensure on time closure. 引领解决产品生命周期中的业务质量相关问题，启动和协调 CAPA，以解决并确保其按时关闭；
- Partner with complaint handling group early capture issues through complaint data trend analysis; Communicate with related functions on issues to address root cause and improve robust complaint closure if it is commercial quality related. 通过投诉数据趋势分析，与投诉处理小组合作，尽早发现问题；与相关职能部门就问题进行沟通，以解决根本原因，并改善与商业质量相关的、稳健的投诉处理流程的关闭；
- Prepare all related certification and documents to support new products timely launch to market. 准备所有相关认证和文件，以支持新产品及时上市。
GSP Compliance 药品经营质量管理规范合规：
- Establish and maintain GSP Quality Management System (QMS)，and ensure quality management system is implemented and maintained 建立并维护GSPf质量管理体系并确保质量管理系统的贯彻和实施；
- Review qualification and approval of suppliers/vendors and customers(related to GxPs), master data management under quality 审核、确认并批准供应商和客户(关于 GxP 等)，以及负责质量职责下的主数据管理
- Ensure that IA are performed at appropriate regular intervals following a prearranged program and necessary corrective/preventive measures are put in place 确保内审按照预定计划以适宜的频率执行，以及必要的纠正预防措施落实到位。
- Review, Approve or Reject all things GxPs 审核，批准/拒绝所有相关 GxPs 的事宜
- Ensure Investigation of Non-conformance, Being involved in any decision to quarantine or dispose of returned, rejected, or recalled products 确保不合格的调查，介入对所有相关退货，不合格，以及召回产品进行隔离或处置的决策。
- As GSP Quality manager, contact regulatory agencies, professional authorities, communicating for the company’s interest pertaining to product quality regulations and industry standard 作为经营公司质量经理，代表公司与政府部门、专业机构，就有关公司产品的法规与行业规范方面的问题进行沟通
Audit and inspection 审计与检查：
- As a GSP/GDP Quality representative, to participate in audit and inspection readiness, Auditing for external and internal audit. 作为GSP/GDP质量代表，参与内、外部质量审计准备，并参与审计过程。
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.