AD, BioResearch Regulatory Compliance 北京

月薪：

该公司所有职位
  • 10年以上经验
  • 本科
  • 招若干人
  • 11-09 发布

职位描述

职位描述： PRINCIPAL RESPONSIBILITIES:Responsible for providing expert strategy, direction, and advice to BRQC and business partners related to global GxP regulatory requirements.Responsible for leading and contributing to the strategic design and implementation of an effective and proactive inspection readiness and management framework to optimally prepare and support inspections.Responsible for leading the coordination of inspection preparation, conduct and post-inspection activities (at least for major inspections).Responsible for providing strategic direction for communication with Regulatory Authorities post inspections, including the Regulatory Compliance review and input to inspection observation responses prior to the submission and the oversight of inspection commitments ensuring documented evidence of completion.Responsible for providing independent and expert strategic direction and advice for Regulatory Authority communications (non inspectionresponse related).Responsible for ongoing monitoring (mining) of external industry and internal J&J inspection outcomes and trends, ensuring this information is proactively shared within BRQC and Business partners and effectively used to shape the Regulatory Compliance mock inspection programResponsible for executing a GXP mock inspection program that proactively identifies areas of inspection risks and tests R&D’s level of inspection readiness.Responsible for performing routine periodic audits of BRQC functions providing assurance that internal BRQC processes are compliant with internal and external requirements.Responsible for leading the conduct or coordination of special investigations.Responsible for supporting BRQC/Business Partners through significant compliance remediation activities, providing expert regulatory compliance advice and solutions.Responsible for external influencing, working with the regulators, defining key strategies for influencing with regional Health Authorities.Responsible for contributing to an effective quality and compliance regulatory Intelligence operation by monitoring global/regional/local regulatory requirements and supporting internal impact assessments for new/changing requirementsIn collaboration with other members of BRQC ensures key business partners and corporate compliance partners are advised of critical compliance issues that relate to Regulatory Authority and ERC activity.Provides strategic leadership, coaching, and mentoring to BRQC colleagues.QualificationsKNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:Requires at least 10 years of experience with 3 plus years experience and demonstrated leadership in a quality function working on complex and significant compliance topics. Must have comprehensive knowledge of worldwide GCP, GLP, PV, and IT compliance regulations and guidelines. Requires knowledge of latest auditing, investigation and remediation techniques as well as leadership experience with inspections.Demonstrated effective influencing, interpersonal, written and verbal communications skills as well as a proven track record of sustaining compliance in complex organizations. Regulatory Authority experience is desirable.BS required. Masters in related field, advanced degree desirable.RELATED EXPERIENCE:Experience with Regulatory Authorities is a significant asset.Experience working with device, diagnostic and cosmetic product classifications (in addition to pharmaceuticals) is desirable.Experience with associated compliance systems such as GMP, GTP, and HCC. 职能类别： 生物工程/生物制药

联系方式

北京市朝阳区建国路77号华贸中心写字楼

公司信息

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国最大的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。 本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。 目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。 2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。

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