莆田招聘

Job Title: Quality Control, Risk Management & Training Manager

Reports to: Head of Quality Control, Risk Management & Training

Job Purpose and Key Responsibilities:
To identify training needs, deliver and coordinate training program in China Medicines Development (CMD).
To develop and implement quality improvement strategies in CMD, ensure clinical trials conducted according to GCP, local regulation and SOP requirements in CMD.
To support on planning and coordinating of risk management activities.

Accountability:
1. Develop and implement clinical quality standard and strategy in CMD
1.1 Develop a comprehensive clinical quality strategy centered on the GSK SOPs and GCP principles and built-in with the key considerations essential for effective implementation in CMD;
1.2 Develop and maintain QC guidance for CMD;
1.3 Monitor the implementation of QC guidance;
1.4 Work with CRA manager, Study Manager to develop a clinical study QC/Co-monitoring plan;
1.5 Support the execution of clinical quality monitoring to ensure the highest possible standard of clinical research in the country is maintained;
1.6 Be responsible for conducting QC visit which is important part of clinical quality monitoring plan and identify quality improvement actions based on the QA results;
1.7 Provide consultancy to CRAs on clinical quality issues;
1.8 Act as an interface to communicating country clinical quality needs to Central;
1.9 Support the Head of QRT with specific clinical quality responsibilities and the execution of those responsibilities.

2. Identify, Deliver and Coordinate training program within CMD
2.1 Act as a local trainer to identify training needs, deliver and coordinate training program within CMD;
2.2 Provide training and consultation to clinical operation team;
2.3 Coordinate and/or deliver initial and ongoing clinical research related training;
2.4 Facilitate and deliver mandatory foundational training to ensure the required level of quality for all new medical staff by (eg: new hire orientation, Monitoring@GSK, Enhancement Monitoring, etc);
2.5 Organize and manage the Clinical Research Forum to ensure that training needs & objectives are met;
2.6 Be responsible for incorporating quality issues into training program and keep training material updated;
2.7 Develop and Maintain CRA and other roles’ Introductory Program within CMD;
2.8 Work with local trainers in other AP countries to ensure experience/learning are shared within the region;
2.9 Work with functional head to identify, plan and coordinate/facilitate the individualized soft skill training for medical staff;
2.10 Coordinate local Learning & Development activities with support from Head of QRT;
2.11 Coordinate LSOP/GUI management to be aligned with global SOP requirement.

3. Act as a point of contact for quality related activities
3.1 Coordinate all kinds of audits in CMD;
3.2 Collaborate with GQC to follow-up and ensure action plans from audits are followed up by CMD/auditee;
3.3 Collaborate with GQC and TQRM to ensure positive feedbacks/leaning from audits to trial team to ensure quality improvements throughout clinical research in GSK trials;
3.4 Support the preparation of regulatory inspection;
3.5 Integrate with TQRM International Local Trainer and Quality Manager Network to reflect feedback and share learning;
3.6 Act as representative from Quality, risk management and training as requested.

4. Contribute to maintain risk management strategy in CMD
4.1 To support Head of QRMT with developing risk management plan of CMD;
4.2 To assist Head of QRMT to implement risk management related training, workshop, QC activities and QC visit.

GlaxoSmithkline/葛兰素史克
作为世界领先的制药业巨擘，葛兰素史克公司秉承以研究开发为基础的一贯理念，凭藉公司本身的技术潜力和资源优势，在当今瞬息万变的医疗保健领域保持强劲的增长势头。
葛兰素史克公司，由葛兰素威康和史克必成强强联合，于2000年12月成立。两家公司的历史均可追溯至19世纪中叶，各自在一个多世纪的不断创新和数次合并中，在医药领域都确立了世界级的领先地位。两个制药巨人的成功合并，为葛兰素史克成为行业中无可争议的领导者奠定了基础，并在全球药品市场中占据有7%的份额。
葛兰素史克公司总部设在英国，以美国为业务营运中心，在抗感染、中枢神经系统、呼吸和胃肠道/代谢四大医疗领域代表当今世界的最高水平，在疫苗领域雄居行业榜首。此外，公司在消费保健领域也居世界领先地位，主要产品包括非处方药、口腔护理品和营养保健饮料。2006年公司在全球的销售总额达232亿英镑。目前，公司在全球拥有10万余名既掌握专业技能又有奉献精神的出色员工。
全球研发中心有1万6千科学家和技术人员分布在全球许多国家。为进一步推动研发全球化，葛兰素史克(GSK)中国研发中心于2007年6月成立。中心将侧重于神经退行性病变的研究，目标是为多发性硬化病、帕金森病和阿尔茨海默氏病等严重疾病开发新药。中国研发中心将发展成有1000多科学家和技术人员的全球研发中心。中心将以科学研究为基础（science-driven），通过生物学，化学以及最新技术，创新开发新的治疗手段。中国研发中心将最终引领GSK在这一领域从识别药物靶标到后期临床研究的全球研发活动，并在中国和其他研究机构密切合作。GSK中国研发中心计划在未来10年内成长为GSK的大型研发中心之一。
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