北京招聘

Job purpose:
The China RA Head PIE has a strategic role in ensuring implementation of the Novartis
Quality Commitment/Manual and its RA relevant Quality Modules within the RA function, and working with other relevant line functions focusing on the intersections. This role ensures that a RA quality management system (QMS) is developed, implemented and maintained.

Your key responsibilities:
?Responsible to act as main point of contact representing the RA at internal audits and external Health Authority (HA) inspections. Be accountable for leading and coordinating the development of appropriate Corrective Actions and Preventative Actions (CAPA) for RA and managing the implementation of all CAPAs at China RA. Provide updates to Greater China RA Head.
?In collaboration with QA, monitor inspection readiness, including quality and consistency measures. Monitor compliance for all relevant processes, in conjunction with QA, through tracking of key performance indicators
?Develop and maintain regularly updated efficient and uniform processes and procedures (SOPs) (RA specific and Development wide) to assure that China regulatory requirements for marketed and development compounds are met, and to support consistency in policies and processes. Work in consultation with relevant SOP governing body, e.g. global RA PIE, CPO/GDD QA.
?Be partner with key GDD Line functions (such as Compliance, Clinical, Patient Safety, TMO), other relevant functions and QA, to ensure integrated high quality processes, that meet regulatory requirements. This includes representing RA and RA management on compliance/quality committees where relevant.
?Ensure implementation of processes/SOPs in RA China. This includes implementation of change control process, oversighting quality KPI and continuous process improvement measures in alignment with relevant process governing bodies, e.g. global PIE and CPO&GDD QA.
ction management of mandatory training of all roles in RA.

Desirable requirements:
?A minimum of 10 years of mainly in a RA environment & closely related areas e.g., GCP/GMP QA.
?Demonstrated leadership in leading initiatives with cross-functional teams and implementation of recommendations
?Must have knowledge of China regulatory regulations.
?Experience and ability to work in matrix cross- functional environment.
?Excellent interpersonal, problem-solving, negotiation and conflict resolution skills.
?Excellent organizational skills, as well as predisposition to process improvement
?Excellent communicator and presenter (oral and written).

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

诺华（Novartis AG）是全球医药保健行业的领导者。其核心业务涉及专利药，非专利药，眼睛护理，消费者保健和动物保健等领域。诺华公司总部设在瑞士巴塞尔，业务遍及全球140多个国家和地区。

诺华（中国）生物医学研究有限公司是诺华全球研发组织――诺华生物医学研究所（NIBR）的第八个研究基地。我们位于中国上海市张江高科技园区，将成为诺华在亚洲的主要研究中心，以及除在欧美的研究中心外的最主要的研究中心。我们的研究和探索开发活动的重点是发现并开发创新疗法，用于治疗在亚洲远未达到医药需求的疾病。我们与从不同之处在于将专注现代药物的发现和开发方法的研究。最初阶段，研发工作将专注在引起中国地方性癌症的感染原因。我们还将开展临床试验，进行安全性研究，生物标志物和检测分析，表达谱、生物分析以及转化医学的研究。

随着公司业务的迅速扩展，我们热忱欢迎您的加入。同时我们将提供具有竞争力的薪酬福利待遇以及良好的培训发展机会。