AM, Lab Support & ASAT, Biologics 生物制剂QC实验室支持与分析科学技术副经理

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The Position

Roche is hiring for a greenfield facility in Shanghai and we are looking for Lab Support & ASAT AM, for who takes responsibility for QC equipment and digital systems, driving lean laboratory management, sample and testing material management,and other lab supporting processes. Also provides support during the project, ensuring both physical and electronic setups meet intended standards and regulatory requirements.

Strong skill and experience are required to cover two areas: System Master Data maintenance and Routine Operation.

● The role supports on the equipment/system qualification and validation, sample/material management and QC Routine operation.

● Work independently and with a level of autonomy and authority in efficient execution to ensure on-going compliance against approved global/local procedure documents, current Good Manufacturing Practices, and CN/EU Annex-1 during the product lifecycle.

● Enable and self-motivate, and demonstrate leadership behavior and mindset

Principle Roles & Responsibilities / Accountabilities主要职责/责任

Routine Operation:

● Oversee and manage the qualification, Computerized System Validation (CSV), calibration, and maintenance programs for relevant laboratory equipment and electronic systems, ensuring strict adherence to Roche’s QMS and regulatory guidelines.

● Direct daily QC support operations, as well as manage and review relevant CAPAs to maintain a global level of GMP compliance. Present technical & system procedure clearly and professionally to internal stakeholders and regulatory inspectors.

● Govern sample and testing management systems(eg account management, DI assessment), to ensure they are in good order to meet the analytical needs any time.

● Guide the team proactively identifying abnormal statuses, deviations, and unexpected results based on detailed data analysis. Lead critical investigations to resolve problems correctly and timely, and effectively escalate major issues to senior management.

● Ensure all necessary processes, documentation (SOPs), and tracking systems are in place and executed Complianced.

● Ensure audit readiness by complying with effective standards, regulatory/statutory, and cGMP requirements. Provide technical support on all lab-related topics during internal and external audits.

● Support all QC activities during regulatory inspections and audits and participate in the response to regulatory and global quality audits.

System Management & Lean Lab:

● Set up master data according to business requirements and ensure data integrity.

● Digital system deployment: Support and ensure on time delivery for QC digital system(eg.LIMS).

● Lead QC system and electric record development according to the project plan and requirment  in alignment with Roche standards.This involves creating a maintenance management system, and an automation strategy(eg. LIMS, Empower, SAP) and implementation to support robust operational readiness.

● Ensure the QC data flow generated by lab equipment/system and maintenance activities are compliance to DI requirements.

● Lead the QC Data Integrity (DI) Governance program: Establish and oversee robust DI control strategies, including routine audit trail reviews, DI risk assessments, and user access management. Ensuring all laboratory processes, electronic systems, and raw data generation strictly comply with ALCOA+ principles and global regulations.

● Ensure all data is maintained in accordance with cGMP and company standards for data integrity

● As the experienced SME, proactive drive the continuous improvement in the Lab support team by leading the taskforce to identify and implement new technologies to improve the compliance and efficiency in routine QC operations.

● Drive operational excellence through the implementation of QC scheduling, lean lab methology and continuous improvement initiatives.

● Support the integration of new technologies and digital tools to enhance lab efficiency and data management.

● Drive QC digitalization and AI technology implementation

Qualification and Experience 能力与经验

Education/Qualifications

● Bachelor’s Degree ( Life Sciences, Pharmaceutical Sciences and Analytical Sciences is preferred) and above

● Strong knowledge of QC operation and maintenance with experience in aseptic processes preferred

Leadership Competencies

● Models Integrity

● Focus on value and customer

● Align for success

● Deliver results

● Learn for the future

Job Required Competencies

● 3 or more years of QC experience, MNC Bio-pharma preferred

● Sound knowledge of quality control procedures and legal standards.

● Sound knowledge of mathematics, data analysis, and statistical methods.

● Experience in strategic project of QC design, commissioning & qualification

● Experience in QC routine operation and QC systems(eg.LIMS, Empower)

● Experience in operation and maintenance of QC operational excellence (eg.Lean and 6 Sigma).

● Have the potential to think strategically and translate strategies into actionable plans, understands and apply agile ways of working

● Strong expertise in the management of laboratory computerized/electronic systems (e.g., LIMS, SAP), with an understanding of or experience with AI-driven tools and digital automation in lab operations.

Fluent in English (both written and spoken), with the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders across the global network.

 

 

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.