Senior QA Manager - China OpCo 40-45k·13薪
上海 10年以上 本科
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The Senior QA Manager - China OpCo for Cytiva is responsible for: ? Collaborate with cross-functional teams to establish quality assurance (QA) strategies aligned with regulatory requirements and industry best practices, which includes perfecting quality standards and implementing quality continuous improvement. ? Accountable for setting & monitoring Quality key performance indicators (KPIs) and identifying & highlighting trends, areas of improvement, recommended actions, and timely execution of those actions. ? Ensure customer satisfaction through case management and quality support for Service & MCS, Fast Trak and Validation Lab. ? Ensure effective communication style and collaborate with stakeholders: work closely with sales, modality, manufacturing site, supply chain, regulatory affairs, product release, and other relevant departments to ensure alignment on quality objectives, resolve quality-related issues, and drive improvements across the entire product lifecycle in a compliant manner. ? Provide guidance and support to cross-functional teams on quality-related matters. In this role, you will have the opportunity to: ? Manage quality metrics and drive quality continuous improvement using DBS tools. ? Lead multiple QA teams including Fast Trak QA, Service &MCS QA and China Case Management Team to achieve quality goals and provide routine leadership and management for the teams that report into this position to drive excellence in quality related functions- including coaching, developing, and performance managing when needed. ? Initiate to establish local Investigation team to accelerate reaction speed to customers’ quality requests for case management. ? Provide training and guidance to enhance quality awareness and compliance. ? Interacts and collaborates with global counterparts, global process owners as well as China local commercial teams to drive business growth. The essential requirements of the job include: ? Minimum, Bachelor's degree, preferably in a Science or Engineering discipline ? 10+ years of experience in Quality Assurance/Quality Engineering within Life Science and relevant environments, minimum of 5 years working at manufacturing site ? Knowledge of NMPA, ISO, FDA, cGMP’s, and CFR requirements ? Be familiar with Customer Complaints, Risk Management, Verification & Validation, Production & Process Controls, Corrective & Preventive Action (CAPA) etc. ? Excellent communication skills in both Mandarin and English ? Ability to manage budgets and travel both domestically and abroad It would be a plus if you also possess previous experience in: ? Demonstrated expertise to effectively communicate within all levels of an organization ? Lab management experience ? Exceptional analytical, problem solving & root-cause analysis skills

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