QC Director_Biologics 苏州

月薪： 60-80万/年

该公司所有职位
  • 10年以上经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： 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.?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. 职能类别： 生物工程/生物制药

联系方式

东平街188号

公司信息

苏桥医药（苏州）有限公司是一家致力于抗体及融合蛋白类生物药物的研发、工艺开发、及中试生产的高科技企业，服务范围全面覆盖临床前研究、临床研究、及商业化生产阶段。总投资额为4,640万美元。 苏桥医药是苏州生物纳米科技园（BioBay）重点扶持的企业之一。苏桥在园区内的建造面积共占地7,000平方米，目标产能1期实现69批次，2期实现92批次。 苏桥将严格遵守国际主流药品监管机构的质量标准，包括CFDA、USA (21-CFR) 、EMA (Eurdralex)、PIC/S以及 WHO。苏桥交付的生产样品能够满足客户在全球多个国家临床试验申请的CMC要求。

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