At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. **The Position** **Main Tasks & Responsibilities** **Product Partnering for reagent products** + Partner with Operations to support outbound product logistics claim. IRM handling, change control and product relevant validation activities. Initiate or participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. + Be responsible for product release and ensure on time release to market. + Follow the priority set from QA Technical Lead, provide resources to make sure achieve results to meet targets and timelines. Provide support to the Quality Systems and Compliance team, as needed. Implement and assist with improvements to Quality system. + Identify and recommend solutions to potential procedure, process and system gaps. + Serve as a OpsQ representative from RDSZ to participate in the design or implementation of departmental / cross-functional / multi-site initiatives. + Embody lean principles and methods while fostering a continuous improvement mindset. Support continuous improvement and implementation of best practices for site. + Be responsible for the setup, deployment and implementation of quality flow in SAP according to Roche Modular QMS **Audit support** + Support internal and external audit and timely provision of records requested by inspectors. + Get involved in internal audit as auditor. **Other tasks assigned by line manager** **Qualification & Experience** **:** + Bachelor’s / Master degree in Life Science or related subject or equivalent experience. + At least five (5) years in the Medical Device/Pharma/Biopharmaceutical industry with 5 years working in Quality, Compliance, Regulatory and/or Validation, preferred or equivalent experience. + Familiar with electronic quality management systems, e.g., SAP, trackwise, Veeva and etc. + Detailed understanding of bio product manufacturing process will be preferred + Well experienced in product development and process validation (3-5 years), have deep understanding of product FMEA and risk assessment philosophy will be preferred + Well experienced in the field of development and implementation of QM / QA processes + Excellent knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards. Demonstrated experience in European, US and other relevant Health Authority inspections. + Familiar with relevant regulatory statutes and industry standards, such as ISO 13485, IVDD, GMP. Experienced with the principles and system processes / tools within the QA/QM field. + Proficient language skills (written and spoken) in Chinese and English Competent with routine application of MS Office, SAP and other common office software. + Skilled in thinking interdisciplinary; creating confident and open relationships within all organizational levels, specifically within matrix organizations. + Independent working style, well-experienced in organizational structures. + Proficient in communicating and presenting topics with business clientele. + Experienced in analysis of QA/QM processes, particularly with respect to compliance, efficiency and effectiveness. + Demonstrated ability to adequately interpret and implement quality standards considered. + Experienced in dealing with all level of authorities including China NMPA officers, TUV auditors, etc. + Professional QM-auditor with specific certification / degree. **Leadership Competencies** **：** + Leadership competencies at proficient level, in line with corporate framework. + Have good experiences in dealing with peers/stakeholders in global culture diversity environment. + Good in conflict management and stakeholder management. + Good communication skills, including communication capability with people from different countries, different industries, as well as interface experts from global functions. + Mutual team player. + Have strong capability to make the balanced decision, ensure both quality/compliance requirements as well as business needs are met in responsible area. + Experienced in people development and new team setup. **Who we are** A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. **Roche is an Equal Opportunity Employer.**