北京招聘

Purpose:

Conducts and supports external interactions, policy and strategy activities as they relate to key Quality activities including global inspection and compliance
Coordinates comments on GMP/GDP related external documents
Manages information regarding external regulations and trends for /input feedback with SMEs throughout the PT organization.
Supports liaisons and interactions with external bodies and committees to influence on technical quality issues through articles, speeches and participation on committees.


Responsibilities

Participates as a key member of teams or committees throughout the global PTQ organization for strategy and policy, external interactions and influencing activities as they relate to Quality and GMP/GDP Compliance.
Support the overall efforts for strong health authority relationships in the areas of Quality and Compliance through effective communications, interactions and participation in meetings, conferences and committees with focus on respective region or area of expertise.
Develop and maintain relationships with industry and regulatory bodies in specific regulatory regions of the world assigned, with specialized expertise in requirements and trends in that region, while being aware of global effects and strategies as they affect Quality and Compliance
Establish and maintain strong, effective positions within key industry/trade organizations including technical task teams, groups or through written media, e.g. technical articles to influence industry positions on key strategic Quality topics
Provide up to date regulatory and compliance information and trends, specializing in specific regulatory authorities and regions, providing timely information to the PTQ organization
Contribute to formal written communications within the PTQ organization updating on the regulatory environment
Contribute to PTQ regulatory , quality and CMC strategies based upon latest regulatory and technical trends derived from industry and regulator interactions and communications
Coordinates with SMEs throughout the PTQ organization to understand their needs, work with outside bodies to influence on these and to engage SMEs in regulatory and industry interactions , meeting and committees including technical journals and other media to influence and collaborate on technical and regulatory issues


Qualifications

Bachelors or advanced degree in technical area; certification or training in quality and technical areas is desirable e.g. ASQ. ,continuing education or in house training
Fifteen or more years' related professional experience in regulatory, quality or process development
Proven ability to be part of a team responsible for the execution of successful innovative GMP and CMC regulatory strategies in the areas of Quality and Compliance
Proven ability to communicate and interact with global health authorities
Expert in the area of Quality and Compliance including primarily GMP/GDP and also CMC issues
Experience with manufacturing, analytical, compliance, and regulatory issues including knowledge of quality systems, quality risk management and their relationship to manufacturing
Prior industrial or regulatory agency experience including leadership roles in applying quality systems to the manufacture of pharmaceuticals through various lifecycle stages
Interaction with industry and professional organizations in manufacturing quality areas to include participation or leading workgroups and giving presentations.
Ability to travel domestically and internationally 30%

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗病毒、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

更多罗氏中国信息，请登陆罗氏官网或访问罗氏招聘公众号。