Director of Quality System Compliance招聘_上海复宏汉霖生物技术股份有限公司最新招聘信息-猎才医药网

职位描述

职位描述： Reporting to: Senior Vice President of Quality & Chief Quality OfficerOpportunity Highlights: This role is responsible for providing expert guidance and direction on all compliance aspects regarding quality system operation in the GMP and ICH compliant Henlius Biopharmaceuticals for new and existing products. This position will act as the Subject Matter Expert (SME) within the organization with the main objective of improving the overall compliance culture throughout the Henlius facilities and sites. This position will be responsible for advising managers and other colleagues on compliance issues and will lead compliance projects when necessary. Primary duties will include identifying the root cause of compliance issues through internal / external audits and regulatory inspections, deviations and OOS investigations, participation in batch review and change control dialogue. Serving the quality system SME, this individual will be responsible for influencing management team on all compliance issues and for developing best practices and action plans according to the GMP regulatory requirements and company quality standards. The incumbent will also be responsible for advising management on internal, external audits and regulatory inspections, with continued business growth. He or she will also play an integral role in a cross functional team focused on new product development.In summary, this is a rare and excellent opportunity to join Shanghai Henlius Biopharmaceuticals during a period of rapid development and growth. This position is highly influential and critical to achieving compliance improvement and as a result contributing to the organization’s strategic goals for continued growth and commercial success.Key Responsibilities:？Responsible for leading and managing Henlius Biopharma’s quality system improvement initiative across all departments and functions to ensure that quality initiatives and quality plans are executed and maintained in full compliance with CGMP requirements. This includes addressing issues from quality management oversight and helping the site management team to execute effectively the quality enhancement activities.？Ensure an effective review on suitability and effectiveness of quality system at defined intervals.？Direct and support the resolution of quality problems in the facility activities so that they are consistent with the industry and company quality standards.？Support and supervise quality governance through review of project documents, KPIs, risk assessments, and quality plans.？Identify and support continuous improvement projects in collaboration with site management team with objective of achieving quality, reliability and cost improvements.？Attend preparation and execution of internal, external and regulatory audits on the site.？Participate in or manage quality assessments related to introduction of new products into the facility.？Review and approve high level quality documents？Ensure that coordinated contact is maintained with other functions, including sharing of better practice and procedures.？Ensure that company executive leadership team is well kept informed of all critical and major quality issues which may have an adverse effect on the product quality.？Perform review of compliance performance at department and individual level and propose corrective actions.？Provide coaching and direction for QA managers and team leaders, and provide training to relevant staff, as requested.？Anticipate risks associated with product quality and regulatory compliance, through the prevention and reduction plans, including management of quality and product alerts.?？Provide quality support and expertise in the GMP projects such as non-conformance remediation plan, tech transfers, GMP facility projects, and the launch of new products.?？Provide support to sites as part of the regulatory inspections and external audits.？Contribute significantly to the development of best practice within the scope of GMP compliance and regulatory requirements; facilitate interaction and exchange of best practices with other departments and functional areas.？Develop GMP and QA knowledge and implementation to its highest standard, which is essential for the company to maintain its strong quality culture.？Representing the quality team, works closely with the heads of other line operations.？Take strategic and leadership responsibilities in bridging between the site and the corporate quality management team.Qualifications:？Advanced degree (MS or PhD) within pharmacy, biology or engineering and with at least 10 years’ managerial experience in a production and/or quality function in the biotechnology / pharmaceutical industry.Experience and Knowledge:？Expert in quality system implementation & improvement, which include but are not limited to Product Release & Production Batch Record, SOP, Training, External & Internal Audit, Regulatory Inspection, Change Control, Data Integrity, Customer Complaint Management, Qualification & Validation, Technology Transfer (Manufacturing Process & Analytical Method), Deviation and OOS Investigation, Quality Risk Management, External Supplier/Vendor Quality System, Quality Agreement, Quality Metrics, and CAPA Management for Non-conformance.？Demonstrated leadership & experience in staff skill development, performance appraisal and department budget management.？Experience in transverse management without direct hierarchical authority or supervision.Key Competencies Required:？Results orientated?？Demonstrated ability to achieve results and manage others to achieve corporate, site and functional objective？Ability to integrate the constraints of each function and identify good solutions while within compliance of regulation？Team performance complemented by development of skills and performance of individual team members？Strong leadership？Strategy development and execution?？Combined strategic and operational thinking?？Focus on goals? with sound judgment？Ability to manage multiple priorities and act with a sense of urgency?？Pro-active and creative by designing new processes and implementation of those to promote process improvement continuously ?？Communication Skill?？Ability to work in highly diversified cultures?？Ability to work in a matrix, multicultural environment？People management and development Skill?？Collaborates and communicates?？Leads others to work together?？Develops team capabilities and staff performance？Rewards and recognizes desired performance？Driven by building interpersonal and a proven team builder 职能类别：药品生产/质量管理生物工程/生物制药

公司信息

2009年12月8日，上海复星医药新药研究有限公司与美国汉霖生物技术公司正式签约合资组建上海复宏汉霖生物技术公司，致力于单克隆抗体药物的研发与产业化。公司位于上海市漕河泾新兴技术开发区，注册资本3000万美元。复宏汉霖主要致力于应用前沿技术进行单克隆抗体药物的开发及商业化，造福更多病患。目前公司正在开发的产品主要覆盖肿瘤、自身免疫性疾病等领域。公司以全球联动整合创新为产品开发的理念，在中国上海、美国加州和台北均设有研发实验室，配备了单抗药物前期研发所需的符合国际化标准的各项仪器设备，其中上海实验室总面积约3,000 平方米，目前在建中的实验室面积约10,000平方米。现已完成单克隆抗体药物开发平台的建设。另外，复宏汉霖率先向国内引进了先进的一次性生产技术，进行单抗产品GMP生产。借助该项优势技术，复宏汉霖现已实现5年5个产品、5项适应症IND申报的高效研发，位于同行业领先地位。展望未来，复宏汉霖人将始终以“开发优质抗体药物，造福全球病患”为使命，不断探索创新，努力耕耘，积极打造深得信赖，领先中国进而影响全球的生物制药企业。复宏汉霖矢志成为国内领先、国际一流的生物制药公司。而人才是公司成功的最重要的根基与动力。期待您的加盟！官网：http://www.henlius.com/

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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