Associate Manager

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.

Ensure quality & regulatory compliance of products manufactured in SRPL by effective management of Quality Control system functions in meeting business goal of company. Provide best practice such as GMP and GLP in Labs to compliance the current global standards.

General

• Managing validation, qualification, and transfer and troubleshooting of analytical methodologies according to current Roche / Genentech requirements and regulations.
• Ensure pharmacopeia compliance in site and support ChP compliance across network
• Manage the sample and reference standard to meet the testing needs in site and in China area
• Manage the stability program to support China business 
• Supporting and executing QC activities related to process and cleaning validation, special analytics, investigations and non-routine testing.
• Managing analytical trending process in labs according to current Roche / Genentech requirements and regulations
• Developing and implementing the new technology roadmap, in collaboration with other QC labs and Global functions or PTD.

Implement GMP compliance with global GMP standards and China GMP requirement

• Sample receipt, storage, distribution and disposal procedure management.
• Reference and retention sample management.
• Excute analytical transfers and local analytical method verifications.
• Ensure process and cleaning validation analysis execution.
• Maintenance of QC specifications and analytical methods.
• Packaging material standard sample management.
• Maintenance of Master Method Validation Plan and the timely execution of method validation protocols and reports
• Third party QC labs management
• Provide technical guidance on test methods and relevant procedures.
• Ensure support on manufacturing operations through troubleshooting and other product lifecycle testing.
• Manage the trending process in labs according to Roche PQS requirements and regulations
• Ensure that CMC regulatory submissions are aligned with QC specifications and analytical methods.
• Ensure that QC specifications and analytical methods comply with applicable pharmacopeias requirements
• Support Chinese Pharmacopeia commenting and implementation across the network
• Stability program - chamber management, coordination with global and laboratories for timely execution of stability protocols and stability report, stability trending
• QC metrics generation and report, managing performance of quality system processes (TCM, Discrepancies, CAPA, etc) for QC
• Reference standards management
• Provide QC technical support and oversight to CMO activities
• Support regulatory inspections and partner audits

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.