QA supervisor /Specialist招聘_上海复宏汉霖生物技术股份有限公司最新招聘信息-猎才医药网

职位描述

职位描述： Overview:The QA supervisor/Specialist-Clinical Management reports to the Chief Quality Officer/VP of Global Quality and provides leadership and management to the Quality in the clinical studies, implementation, administration, and documentation of clinical study related Quality Management System and its associated standards and systems to ensure that clinical trials are conducted and data is generated, documented, and reported in compliance with internal standards, GxPs, ISO 9001 and relevant and applicable regulatory requirements. Perform duties in accordance with company’s values, policies, and procedures.Responsibilities:Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion. Oversee, coordinate and provide senior leadership and strategic direction for Quality and its implementation across Profil Clinical Research sites.Actively participate as a member of the Profil Management team and communicate cross departmentally regarding Quality strategy, issues and processes.Plan and coordinate the implementation and management of the company quality management system to ensure compliance with all applicable regulations (GCP, GLP, GMP (GxPs)) and state laws, and to meet ISO standards for clinical trials in phase I research.Oversee and contribute to building and maintaining appropriate documentation for all aspects of the company quality management system to include but not limited to quality policies, standard operating procedures (SOP), training records, equipment, management, computer systems and device records for clinical trials.Acts as company ISO Management representative.Oversee and contribute to the planning and the conduct of internal Quality Assurance audits.Oversee and contribute to client initiated audits and regulatory inspections.Oversee and contribute to third party vendor audits.Coordinate with IT on management of computer system validations and equipment requirements for management of clinical trials.Oversee and contribute to the development and maintenance of SOPs and other controlled documents.Oversee the management of eDocument Management System for SOPs and other controlled documents.Oversee and contribute to the CAPA process to evaluate corrective and preventive action plans as applicable following non-compliance with regulations, study protocols and/or SOPs and other controlled documents.Participate as a mandatory CAPA board member.Plan and manage the Quality Department associated infrastructure, team and budget.Oversee staff including fostering team building, positive communication, and corporate culture.Plan and oversee the management and delivery and documentation of internal training and continued education as relevant for the organization.Supervisory Responsibilities:Manage the QA teams across Profil sites including the Senior Managers and, carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include workforce planning, interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Education/Experience:Bachelor's degree (B.A.) from a four-year college or university in Life Sciences or related field with 10+ years Quality Assurance Management experience, 5+ at Director level required, 5+ Early Phase Clinical trial management and/or QA experience, and 2+ ISO 9001 experience.Skills, Knowledge, and Abilities:Advanced knowledge of US and International Regulatory requirements for clinical research including FDA/ICH-GCP; knowledge of ISO 900; demonstrated leadership skills; strong judgement, initiative, and problem solving skills; high level team development and leadership skills. 职能类别：生物工程/生物制药药品生产/质量管理关键字：周末双休年终双薪带薪年假交通补助话补

公司信息

2009年12月8日，上海复星医药新药研究有限公司与美国汉霖生物技术公司正式签约合资组建上海复宏汉霖生物技术公司，致力于单克隆抗体药物的研发与产业化。公司位于上海市漕河泾新兴技术开发区，注册资本3000万美元。复宏汉霖主要致力于应用前沿技术进行单克隆抗体药物的开发及商业化，造福更多病患。目前公司正在开发的产品主要覆盖肿瘤、自身免疫性疾病等领域。公司以全球联动整合创新为产品开发的理念，在中国上海、美国加州和台北均设有研发实验室，配备了单抗药物前期研发所需的符合国际化标准的各项仪器设备，其中上海实验室总面积约3,000 平方米，目前在建中的实验室面积约10,000平方米。现已完成单克隆抗体药物开发平台的建设。另外，复宏汉霖率先向国内引进了先进的一次性生产技术，进行单抗产品GMP生产。借助该项优势技术，复宏汉霖现已实现5年5个产品、5项适应症IND申报的高效研发，位于同行业领先地位。展望未来，复宏汉霖人将始终以“开发优质抗体药物，造福全球病患”为使命，不断探索创新，努力耕耘，积极打造深得信赖，领先中国进而影响全球的生物制药企业。复宏汉霖矢志成为国内领先、国际一流的生物制药公司。而人才是公司成功的最重要的根基与动力。期待您的加盟！官网：http://www.henlius.com/

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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