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The Global Clinical Quality Manager is responsible to partner closely with the Clinical team members to maintain processes that ensure activities are conducted consistently and in compliance with applicable Dizal procedural documents, applicable global regulations, guidelines and standards toward the goal of inspection-readiness. Planning and implementation of the quality control activities and oversee the learning needs and trainings delivery as related to Quality assurance.
Role & Responsibility主要职责
Responsibility:
Oversees the development and implementation of Quality Control strategy and activities for Clinical Operation team. Oversees generation, review and compliance of developed and approved procedures with company-wide
quality policies and standards.
Responsible for the development, maintenance and the communication of high quality standards in the delivery of clinical studies.
·Secures and improves quality in Clinical Operation by providing training, implementing QC activities and driving quality initiatives.
·Provides compliance and process advice to study teams and identifies opportunities for quality and process improvements.
·Responsible for the development, implementation and continuing review of procedural documents, and maintains current knowledge and understanding of regulations and industry practices in relation
to clinical trials.
·Supports audits and inspections and is the main contact for auditors from Clinical Operation team. Advises and monitors Clinical Operation team in the planning and implementation of all quality control activities and uses risk
management to evaluate compliance issues and develop solutions.
·Provide co-monitoring visit according to the alignment with study lead.
·Ensures annual study and system QC plan in place, facilitates and monitors the implementation of QC activities by Clinical Operation team.
·Analyses quality status of the function, identifies risk/root cause and comes up with CAPA
·Advises Clinical Operation team on CRO quality management
·Advises/Supports the local study team in the preparation for, conduct of and responses to audits and regulatory
inspections.
·Advises local study team in the resolution of the findings in audit and inspection reports. Gives regular feedback/training on audit and inspection findings to Clinical Operation team.
·Shares learnings from audits and inspections with study team. Identifies and ensures resolution of potential risks based on previous study/systems QC results, audit and inspection results.
·Works with LMs to ensure the training compliance within function
·Identifies and organises/provides on-going and ad hoc training to Clinical Operation staff according to training needs :
introductory training to new staff, including Procedural Training
ad hoc local training
solutions e.g. as result of serious or recurring quality issues
(be involved in) other initiatives to identify and share best practices
·Identifies opportunities for quality improvement and leading any optimization/simplification of relevant
processes
·Provides training to Investigational Site staff on GCP, ICH and local regulations, if support needed by local study team
·Creates an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspires teams to achieve goals in the immediate and long term . To be an active and
visible change agent, promoting flexible and open mindsets to new opportunities.
·Perform gap analyses relating to new and changing regulations, policies, guidelines and standards.
Education, Qualifications, Skills and Experience 任职要求
Job Requirement:
·University degree (or equivalent), preferably in medical or biological sciences or discipline associated with
clinical research. Advanced degree is preferred.
·At least 5 years’ experience from within the pharmaceutical industry or similar organization or academic
experience.
·Procedural Documents generating experience.
·Good understanding of the drug development process and related GXP activities
·Good understanding of the skills and knowledge required for the successful delivery of a clinical study,
eg. ICH-GCP, study management, site management, monitoring and local
regulations
·Good knowledge of local and international regulations and guidelines
·Ability to monitor the internal and external working environment and enable changes to drive quality,
simplification and efficiency
·Ability to look for and champion more efficient and effective methods/processes of delivering quality
clinical trials with reduced budget and in less time.
·Good written and verbal communication skills
·ability to prioritise and handle multiple tasks
·Good analytical, problem solving, negotiation and conflict resolution skills.
·Demonstrated ability to set and manage priorities, performance targets and project initiatives in a global
environment
·Strong interpersonal skills, with the ability to work effectively with others at all levels of the
organization
·Excellent cultural awareness.
·Integrity and high ethical standards
Able to read and interpret technical procedures and regulatory requirements
·Experience providing work direction to teams
·Continuous improvement mindset Collaborative, team player
The R&D (Research and Development) team of Dizal Pharma was AstraZeneca Asia and Emerging Market Research Center. As one of AstraZeneca’s first four R&D centers across the world, it dedicated to analyze the potential scientific mechanism of those most common diseases in Asia and fulfill the particular medical needs of Asian patients. It was one of the few R&D centers established by transnational pharmacy enterprises in China which had the ability to actually research, develop and produce micro-molecular new drugs, the ability to develop produce new drugs independently and completely, and the first-class medical platform in the world.
迪哲医药,于2017年10月独立运营,是一家研发驱动型生物医药企业,致力于全球创新药物(First-in-class/ Best-in-class)探索、研发以及商业化。
迪哲医药的前身为阿斯利康亚洲及新兴市场创新研发中心,设立于中国上海,是阿斯利康全球四个研发中心之一(另三个中心分别位于英国剑桥、瑞典哥德堡、美国盖瑟斯堡);是国际一流、高产出的创新药研发机构,拥有全球领先的转化医学和新药分子设计与筛选技术平台;在恶性肿瘤、自身免疫性疾病、肾病等重大疾病的新药研究方面积累了丰富经验。