上海招聘

Quality Alliance Leader

1-Introduction/Purpose

As a Quality Alliance Leader you are accountable for establishing and maintaining strong relationships with key business partners and implementing a comprehensive Quality strategy.

2-Responsibilities and Accountabilities:

- You will develop and implement a comprehensive quality strategy for the key business partners (Roche Pharma departments).

- In this role you ensure that partner expectations for quality assurance and services are met and that PDQ is providing efficient, effective, value added support across the organization.

- You identify Subject Matter Experts (SMEs) with or outside PDQ who work with the business partners ensuring partner’s quality management plans meet the requirements of GCP and PV regulations.

- You raise awareness and understanding of the Quality Management System (QMS) requirements to the senior management of the function and provide clarity on role & responsibilities between PDQ and the business partners.

- Pro-actively identify areas of systemic quality issues / risks, training or process improvement and determine ways in which PDQ can help to improve quality.

- Contributes to the PDQ Partner Services Team to set strategies and achieve the long-term goals & objectives for PDQ as a whole.

3-Qualifications - Internal

Education/Qualifications:

- PhD, MSc or equivalent in an appropriate scientific discipline.

- Significant experience in various aspects of the international pharmaceutical clinical development process (Phase IIV).

- Expertise in the principles and practices of Quality Management and/or GCP/PV audits.

- Demonstrated knowledge of GCP, GLP, PharmacoVigilance / drug safety and regulatory requirements, as well as analytical, organizational and planning skills.

- Management of projects with cross-functional involvement and complex timelines preferably in a Quality environment.

- Strong interpersonal and stake holder management skills, including a customer focused approach, and highly effective teamwork and collaboration skills.

- Ability to build and maintain excellent relationships with key business partners.

罗氏药品临床研发亚太中心

罗氏药品临床研发亚太中心位于上海张江高科技园区，是罗氏在中国乃至亚太地区（不包括日本在内）第一个全功能临床药品开发中心，是罗氏药品开发部在全球的第五个研发地区。其前身为2007年10月成立的罗氏药品开发中国中心。

罗氏于2007年在中国率先设立全球药品开发中心，成为在华完成且体现药物研究、药品开发、生产制造和市场销售环节等整体价值链布局的跨国制药企业。此举不仅将加快新药在华的上市时间，使国内广大患者有望更早地受益于创新药物，而且将让更多的中国研究机构、学者、临床医生更早、更主动地参与到全球创新药物的开发过程。

罗氏药品开发中国中心从事药品开发工作，是把经过实验室筛选的分子转变成药物的关键一环，它通过国际多中心临床研究，鉴定药物的安全性和有效性，是驱动药物价值链的引擎。罗氏药品开发中国中心于2009年9月升级为罗氏药品临床研发亚太中心，负责罗氏在亚太地区的药品开发，令更多中国乃至亚太地区的患者尽早受益。