上海招聘

Job Description

-Develops Carsgen Clinical Quality Management Strategy

-To develop and implement clinical quality oversight plan via conduct quality control activities to ensure clinical trials conducted according to GCP, China regulations and SOP requirements

-To support on planning and coordinating of risk management activities

-To identify clinical operation training needs, coordinate training program and deliver training

Key Responsibilities:

-Develop, maintain, and oversee GCP quality management process including internal SOP for clinical development activities in Carsgen.

-Develop Study Quality Oversight Plan for Carsgen sponsored clinical trials and conducts quality oversight visits of clinical trial sites, contract research organizations (CRO) and suppliers.

-Develop (or work with QA vendor) on QA plan and conduct audits of clinical trial sites, suppliers, protocols, and study reports and report all audit observations to clinical sites and Carsgen management.

-Conducts system and process audits as required, e.g. pharmacovigilance, data management, safety and clinical operations etc.

-Maintains GCP regulatory compliance and quality performance within Carsgen.

-Responsible for communicating quality issues to internal stakeholder, including resource requirements to maintain QA compliance.

-Prevent and mitigate quality risks that can jeopardize Carsgen interests (patient safety, supply continuity, reputation).

-Conducts audits of clinical trial sites, suppliers, protocols, and study reports and reports all audit observations to clinical sites and Carsgen management

-Drive a continuous improvement / on-going development mind-set together with clinical operations team and management

-Manage Quality metrics and key process indicators reporting through monthly quality reporting

-Execute quality compliance activities: SOP approval, deviation documentation and CAPA

-Establish and execute GCP training programs

-Establish audit program for Carsgen sponsored clinical trials

-Host local regulatory and health authority inspections

Qualifications:

-Minimum of a Bachelor of Science degree in Medicine, Pharmacy, Biology or Nursing from an accredited college or university

-A minimum of 6-8 years of pharmaceutical company clinical development experience with at least 3 years’ GCP auditing experience in clinical research.

-Experience and active participation in health authority inspections as well as performing clinical site, readiness inspections

-Working knowledge of Pharmacovigilance systems and processes is highly preferred

-Extensive knowledge of cGCP QA and compliance programs

-Extensive knowledge of ICH E6 and associated CFDA and regulations is a must

科济生物简介

科济生物医药（上海）有限公司（以下简称“科济生物”）是聚焦于CAR-T细胞、抗体等肿瘤免疫治疗药物的创新型生物医药企业。

科济生物成立于2014年，总部位于上海，在中国和美国设有实体运营中心。目前公司已建立了广泛的CAR-T候选产品研发管线，开发了能够覆盖大部分实体瘤及血液肿瘤的高效特异性CAR-T及抗体药物候选产品，以满足日益增长的医疗需求。公司已率先启动了多项治疗复发/难治性实体瘤的CAR-T临床研究项目，包括针对肝细胞癌（HCC）和肺鳞癌的CAR-GPC3-T项目，CAR-EGFR / EGFRvIII-T试验用于胶质母细胞瘤，CAR-Claudin18.2-T用于胃癌和***癌等的临床研究。目前科济生物已经获得多项国内外的CAR-T细胞新药临床试验许可，其中BCMA CAR T细胞药物还分别获得美国和欧盟药监局的"再生医学先进疗法（RMAT）"和"优先药物（PRIME）"资格。

此外，科济生物还拥有治疗性抗体药物的研发平台，其领先的针对Claudin18.2的人源化单克隆抗体已获得国家药监局（NMPA）的IND批准。

  展望未来，科济生物将秉承“科创济世”的价值观，积极与国内外顶尖研究机构、知名医院合作，推进各种先进治疗手段的研制，从而造福更多肿瘤患者。