Director/Sr Director,Quality Control

面议

苏州市本科及以上

刷新时间：2021-04-26

职位描述

Summary/概述: Provide leadership and direct the daily activities of the Quality Control department and functions at CMAB’s- Suzhou manufacturing facility. Establish and maintain Analytical and Laboratory controls to ensure compliance with applicable regulatory and internal requirements.

Principal Duties and Responsibilities/主要职责（包括但不限于） − Responsible for oversight and direction Quality Control operations at CMAB’s Suzhou manufacturing facility. − Support Head of QA acting as interface representing quality control (QC) in intra company and client/customer interactions. − Support quality operations in oversight for corporate facilities and operations to ensure compliance. − Support CMAB business development group’s client development and technical requirement. Involving client’s DD and technical meeting. − Responsible for the establishment of the functional quality control (QC) organization --- Analytical, QC Environmental Monitoring, and QC Stability to support the CDMO operation. − Implementation of corporate Quality Control Management Systems aligned with CMAB strategic and corporate objectives spanning the following areas: − Analytical Transfers − Analytical Method qualification & Validation − Laboratory Controls − Establishment and maintenance of QC specifications as required − Process and cleaning validation. − Generation and maintenance of Master Method Validation Plan − Management of Third Party QC Labs and Support Service providers − Provide technical support at the SME level for guidance on test methods and procedures − Assist in trouble shooting of MFG processes in support of process development and clinical manufacturing − Lead non-routine analysis in support of investigations − Act as project lead (or senior team member) for selection, implementation, qualification and validation of Laboratory Information Management System(s) (LIMS). − Provide cross functional support to internal CMAB departments to ensure sustainability and continuous improvement in all compliance and quality functions. − Participate as quality representative (or provide delegate) in site safety and safety compliance. − Participate as a standing member of the Quality Management Review committee. − Commercial Management
− Member of company senior management team. − Representing the company to external parties with focus on GMP compliance. − Recruiting and management of Quality Assurance and Quality Control Staff − Selecting, approval, and management of preferred contract service providers in partnership with Engineering and Facilities to perform supplement internal capabilities and capacity. − Preparing budget and management of expenditure in line with budget for quality functions and activities. − Approval, and where required preparation, of capital expenditure requests for site improvement and renovation projects.

Job Requirements/工作经验  B.S. (preferably Biology or Chemistry) plus a minimum of 7 years responsibility in the management of quality and compliance systems for the manufacture of therapeutic biologics.  At least five years of operational experience in a regulated biopharmaceutical manufacturer with exposure to facility start-up.  Thorough knowledge of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) encompassing documentation and operation of pharmaceutical facilities including Eudralex, PIC/S and US-FDA with focus on biological API and sterile product manufacture.  Detailed knowledge in the design, implementation and maintenance of Quality Control Operations and Systems for global compliance.  Thorough understanding of mAb development, manufacturing, and analytical process.  Experienced in supporting/managing and/or maintaining a robust change management system:  Document Management  Change Control  CAPA and Deviation  Training  Experience in managing project teams of at least 20 people.  Experience in participation of capital projects of US$20m or greater.  Preferably a member of ISPE and or PDA  Demonstrated capability and enthusiasm to establish high-performance teams.  Advanced computer system and database skills.  Ability to investigate and solve complex technical problems  Excellent communication skills in Chinese and English to engage with personnel from multiple disciplines and experience bases across the operations organization.  Exposure to company and facility start-up.  Strong prioritization and organization skills.  Detail oriented, flexible, self-initiative.

其他要求

招聘人数：1人
职能类别：质量部经理/主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。