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Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
Principle Roles & Responsibilities / Accountabilities
(Major functions of the position)
Quality Oversight
Collaborate with key stakeholders including manufacturing operations, supplier quality, quality systems and Planning; provide Quality oversight in Drug Products life cycle and the E2E manufacturing/packaging process
As per the business arrangement, the scope of quality oversight should cover the quality activities in all related areas including warehouse operation, QC laboratory, production plants, site PUW, PW, Environmental Monitoring (EM) and Clean Utility Monitoring programs, etc.
Manage and oversee frontline QA activities in plants.
QA activities
Manage of sampling process for local manufactured/packaged products
Perform oversight of Specification, process and product monitoring for local manufactured/packaged products
Perform oversight of stability program for local manufactured/packaged products
Connection with Global QPL, take role as quality role across the local manufactured/packaged product life-cycle management (Local QPL Role)
Execution of frontline QA activities in plants
QA-Acknowledge the live status in production area according to the DPS and follow up with actual excursions against the DPS, identify the potential risks and take preventive action.
Join Tier meeting in production or other Tier meeting
Perform batch record revie
Enabling real-time problem solving with production team
Implement local manufactured/packaging product-related batch release process
Ensure on-time batch disposition per Roche OLT and ATL
Ensure products are not sold or supplied before a QP/AP has released, each production batch is produced and controlled in accordance with the requirements of the Marketing Authorization and other regulations relevan
Perform the interaction with EU QP regarding exported batches.
Execution of API/direct materials management
Ensure on-time material batch disposition per Roche requiremen
Implement oversight of material quality including Specifications, Artwork, SAP/MES master data, Change, DMS/CAPA, new material qualification, quality management etc
Support local supplier quality management including audit, Quality Agreement etc.
Coordination and handling for quality related issue
Implement the management of UPE(deviation and critical deviation)：Be familiar with RCA tools and can independently facilitate related departments to conduct discrepancy investigation, ensure the investigation completed within specified due date and supporting products release
Collaborate with SMEs and Lead investigators to develop investigation strategie
Provide leadership for Local CAPA Review Board and participate in Quality Council when neede
Monitor investigation progress and ensure effective corrective and preventive actions are initiated and executed on time and keep continuous improvemen
Be in charge of Quarterly review and yearly review of Discrepancy to seek continuous improvement opportunitie
Handle UPE (customer complaint)
Perform customer complaint investigation and ensure effective corrective and preventive actions are initiated and executed on time
Handle customer inquiry
Quality system oversight
Execute QA process/documentation maintenance in a continuously compliant state and a continual state of readiness for regulatory agency inspection
Manage product recall & mock recal
Manage product return, material destructio
Manage repackaging of finished products and labeling management for donation products
Execute the business process management (BPM) of CAPA, UPE (complaints and deviations)
Other quality related activities
Support to draft and review the local product APQR.
Involve and support the inspection by HA and Roche Global inspection.
Logistic Service Provider audit & bidding supporting.
Involve quality related projects.
Complete other tasks assigned by senior leaders.
Manufacturing, Engineering, Local MSAT, Planning, Warehouse, Safety, Medical and Regulatory affairs
Other Quality Functions
PQS document owners/authors
Cross-site and global BPms for UPE and CAPA
Global Functions: Regulatory (PDR), PT Development, QPLs, TPLs and EU QP.
Qualification and Experience
Education/Qualifications
Job Required Competencies
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche China consists of the full value chain of Pharmaceuticals and Diagnostics fields, from early research, clinical development, manufacturing to commercialization. With more than 7,000 employees, Roche China is now working to develop itself into Roche's third global strategic center after Basel and San Francisco, and making sustained efforts to fulfill its long-term commitment to China, so as to meet Chinese patients’ unmet needs.
Roche is an Equal Opportunity Employer.
