QS&C Associate Manager_System Digitalization 质量体系及合规副经理（数字化系统方向）

Job description

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 Quality and Technical Guidance Support mobilisation of new sites from a quality, compliance perspective. Lead or support the local implementation of global quality computerized projects (e.g., ASPIRE) by driving master data readiness, conducting end-to-end scenario test preparation and execution, SOP establishment/revision, and end-user knowledge sharing, and performing hypercare incident troubleshooting to ensure a smooth go-live Lead the master data maintenance role in daily business operations on the quality computerized system(e.g. the Aspire project), including but not limited to master data management, resolving issues in a timely manner to keep the business running smoothly, maintenance of S/4 and BRH system execution procedures and BCP.

Identify, assess, and escalate potential computerized system quality module operation risks, and develop practical mitigation strategies and solutions to keep system running smoothly and meet business needs. Serve as a key contact for computerized system quality modules and provide technical and process support to cross-functional business partners. Collaborate to resolve computerized system quality modules issues, remove technical barriers, and ensure successful delivery of project/system objectives.

Provide ongoing operational and maintenance support for computerized system quality modules after go-live. Continuously assess the business suitability of system processes, gather user feedback, and lead process enhancements and continuous-improvement initiatives to ensure that the systems continue to support evolving business needs. Perform other duties as assigned by the line manager. Education/Qualifications The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline.

Good knowledge of all relevant GxP and Quality System requirements ( EU) for pharmaceutical and biotech, manufacturing and related activities. Experience on regulatory inspections with Health Authorities and of interacting with representing the company to Health Authorities, their agents, or related entities.

Job Required Competencies

A minimum experience of 4 years in the pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company. Rich hands-on experience with tools like SAP, Veeva, and demonstrating strong stakeholder management, independent problem-solving, critical thinking abilities, and agile skills with flexibility to adapt to changes. cGMP know-how and a thorough understanding of ICH guidelines, together with exposure to the international network.

Aseptic Filling experience is expected. An ability to interact and communicate with all types of personalities in an effective and diplomatic manner Good decision-making capability Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders. 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.