上海招聘

Position Title: Quality Assurance, Manager / Consultant / Senior Manager

Position Summary

Responsible for the initiation, conduct, and implement of quality assurance activities and audits to assure adherence to SOP, and any applicable regulatory requirements. Responsible for the establishment and improvement of quality management system including SOP, documentation system and training program for GCP and relevant regulatory compliance. Coordination and management of inspection support, conduct of investigations of scientific misconduct and serious GCP noncompliance, and the handling of outsourced activities performed by external consultants on behalf of QA as business needs. Provide other QA related support as needed.

Key Responsibilities

I. Ensure adherence to applicable regulations, customer / sponsor requirements and quality standards of the clinical programs.

1. Independently manage and perform compliance audits of Process, Execution, Systems, Documentation, during each phase of the clinical trial processes. Such as Investigator sites, Clinical and analytical laboratories, drug packaging and distributors, Phase I Unit, Suppliers / vendors, etc. Lead and involve in audit activities such as IVRS, central labs, monitoring, data management, filing/archiving, medical writing, study start up, monitoring etc.

2. Lead and support the validation activities for computer system and databases. Ensure compliance of the study deliverables in respect to protocols, CRFs, TMF, clinical study reports, study files, table & listings, etc.

3. Be accountable to lead the initiatives and actions for regulatory inspection readiness, such as conduct mock regulatory inspections, provide training to prepare dMed staff and investigator sites for inspections, assist preparing responses to inspection findings, etc.

II. Provide quality assurance leadership and consultation for industry best practice.

1. Implement corrective and preventive action (CAPA) process to ensure the company to investigate significant out-of-specification events, deviations & discrepancies, report the findings and conclusions of the investigation, implement and document corrective actions.

2. Establish and maintain preventative review and calibration programs, as applicable, to ensure operational process and systems are appropriately and effectively support compliance to regulatory requirements, SOPs and quality standards. ？

3. Conduct unbiased assessments of all aspects of a study or operational process, including auditing clinical sites and associated databases, validating software, assuring quality of reports, study files, tables & listings, or vendors, etc. ？

4. Develop, update and maintain company SOPs, ensure SOPs training completion and compliance ofall staff, and maintain accurate documentation of SOPs and training files.
III. Acts as GCP QA representative and expertise to provide quality and continuous improvement consultation and support internally and externally.

1. Represent QA on various company/project/study team meetings.

2. As requested by individual contract, may represent the sponsor/client during regulatory inspections, external audit. This will include preparation, coordination and communication.

3. In liaison with management, manage cases and corrective actions for scientific misconduct and serious GCP non-compliance.

4. Take lead and collaborate with relevant functions and parties to develop risk mitigation program and action plans ？ Popularize general GCP principle to all staff, and provide knowledge updates in areas pertaining to GCP Regulations/ Guidelines/ Good Practices through review of literature and participation in relevant internal & external meeting/workshop/symposia.

5. Support the coaching of less experienced and/or newly hired staff.

Education and Key Competency Requirement

I. Professional Experience & Education Requirement

1. Bachelor degree in a life or medical / sciences or relevant scientific discipline.

2. At least 6 years of relevant biopharmaceutical industry experience, and prior quality assurance and quality control experience with solid knowledge of GCP or GXP requirements and guidelines.

3. Experience in performing independent GCP audit and inspections is required. Proven ability to independently interact with all internal (e.g. Projects Teams, Trial Operations etc.) and external (e.g. Sponsor/Vendors / Client) parties involved in the audited clinical research activities.

II. Key Competency Requirement

1. Thorough knowledge of ICH Guidelines and GCPs including regulatory requirements for the conduct of clinical development programs.

2. Strong understanding of quality system regulations and requirements, and ability to assess and implement improvements to the existing system.

3. Superb organization, communication and teamwork skills and strong interpersonal skills to be able to effectively interact with customers, multidisciplinary groups as well as with vendors.

4. Good analytical and issue identification abilities, and attention to detail.

5. Creative problem solver and keen ability to address current and anticipated issues

6. Self-starter with high energy level and strong results orientation.

7. Ability to travel as needed.

备注：‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。

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创始人及部分核心专业领域


创始人 - 谭凌实博士：拥有20多年跨国一流制药公司总部高级管理经验。此前担任辉瑞公司全球药物开发运营副总裁，在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点，成为辉瑞全球核心的研发中心之一，承担药物临床开发、安全风险管理、注册、临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作，比如复旦大学、北京大学，交通大学。培养了不少拥有专业技能和行业知识的临床数据管理和编程人才。谭博士有在美国建立初创企业的经验，且在美国一流制药企业研发中心工作多年。谭博士拥有生物统计博士学位。