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The Position

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.

Key Interfaces:

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

Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent education level)Graduate or higher-level Degree is preferred

Job Required Competencies

Experience (may vary depending on site size/scope)5 or more years’ work experience in the pharmaceutical or related industry3 or more years’ experience in a commercially licensed GMP facilityKnowledge/Skills/CompetenciesProfessional knowledge of Quality System and QA principles, practices and standards for the pharmaceutical industryRich knowledge of cGMP relevant to the pharmaceutical industrycGMP knowledgeKnowledge of pharmaceutical, biotechnology or medical device related product operations including local and international quality regulations.Project management skillsDemonstrate good verbal and written communication skills in EnglishFocus on value and customerLearn for the future

Who we are

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.