Manager, CMO Quality 经理，委托加工质量管理

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 1. Principle Roles & Responsibilities / Accountabilities Selection & Implementation Phase Oversee all required Quality activities for technical product transfer & launch during Implement phase at CMOs including GMP commissioning, oversight of validation activities and GMP document approval. Oversee all required Quality activities for method transfer and test/specification readiness during Implement phase at Roche site including oversight of validation activities, release/stability testing and GMP document approval. Oversee material supplier selection, qualification, and approval throughout the project lifecycle, and ensure the Approved Supplier List is provided to the CMO for GxP execution. Develop, negotiate and maintain Quality Agreements with CMO and ensure compliance with agreements. Provide as needed support during regulatory inspections and cGMP compliance audits, collaborating with CMOs to ensure on time closure of associated CAPAs when requested. Coordinate and facilitate CMC submissions, variations and dossier updates as applicable with Roche Technical Regulatory and CMO. By communication of the specific quality topics Commercialization Phase Manage all required activities to support Make Assess Release (MAR) of commercial product including approval of process related documentation as agreed in Quality Agreement, investigations handling, assessment of change controls, and monitor and report CMO quality performance. Oversee complex investigations in partnership with CMO, and management of the Quality Review Board process and application of effective Root Cause Analysis (RCA). Perform quality complaint investigations with CMOs and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness. Ensure that CMO provides Annual Product Quality Reviews, and other GMP documents in a timely manner and right first time. Define and deploy the schedule for Quality Oversight in CMO sites. Support the job of maintaining the business needed licenses. Lead and promote the continual improvement of quality management system in CMO site Complete other tasks assigned by senior leaders 2. Key Interfaces Quality, Manufacturing, Engineering, Planning, Warehouse etc. in CMO sites Quality and Technical Transfer Team in Roche network PTR, PV 3. Qualification and Experience Education/Qualifications Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent education level) Graduate or higher-level Degree is preferred. Leadership May mentor and/or coach colleagues their knowledge / skill within and outside the organization. Contributes by participating in large/global cross-functional or cross-chapter squads where it may take a leading role. Navigates in complex situations by applying a diverse skillset. Job Required Competencies Experience (may vary depending on site size/scope) 7 or more years’ work experience in the biopharmaceutical or related industry 5 or more years’ experience in a commercially licensed GMP facility Preferred experience with contract manufacturing organizations Knowledge/Skills/Competencies Expert knowledge of Quality System and QA principles, practices and standards for the pharmaceutical industry Expert knowledge of cGMP relevant to the pharmaceutical industry Strong knowledge of pharmaceutical, biotechnology or medical device related product operations including local and international quality regulations. Project management skills Demonstrate excellent verbal and written communication skills in English Focus on value and customer Learn for the future 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.