Senior Specialist/Associate Manager, QA Solid

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

Your Opportunity:

1. 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 process.

• As per the business arrangement, the scope of quality oversight should cover the quality activities in all related areas including QC laboratory, production plants, site PUW, PW, Environmental Monitoring (EM) and Clean Utility Monitoring programs, etc.

• Manage and oversee frontline QA activities in plants.

• Manage of sampling process for local manufactured products.

• Perform oversight of Specification, process and product monitoring for local manufactured products.

• Perform oversight of stability program for local manufactured products.

• Connection with Global Quality, take role as quality role across the local manufactured product life-cycle management.

• Execution of frontline QA activities in plants.

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 meetings

Perform batch record review

Enabling real-time problem solving with production team

2. Implement local manufactured product-related batch release process

• Ensure on-time batch disposition per the requirement of Roche Timeline.

• 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 relevant

• Perform the interaction with EU QP regarding exported batches.

3. Execution of API/direct materials management

Ensure on-time material batch disposition per Roche requirement /

• Implement oversight of material quality including Specifications, Artwork, SAP/MES master data, Change, Deviation/CAPA, new material qualification, quality management etc.

• Support local supplier quality management including audit, Quality Agreement etc.

4. Coordination and handling for quality related issue

• Implement the management of Event&CAPA：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 strategies

• Monitor investigation progress and ensure effective corrective and preventive actions are initiated and executed on time and keep continuous improvement

• Handle customer complaint

Perform customer complaint investigation and ensure effective corrective and preventive actions are initiated and executed on time

Lead the investigation of local manufacturing products related complaints.

5. Quality system oversight

• Execute QA process/documentation maintenance in a continuously compliant state and a continual state of readiness for regulatory agency inspections

• Oversee the Quality Process of Material Quality Management and Manage material quality management in site.

6. Other quality related activities

• Support to draft and review the local product APQR.

• Involve and support the inspection by HA and Roche Global inspection.

• Involve quality related projects.

7. Complete other tasks assigned by senior leaders

• Manufacturing, Engineering, Local MSAT, Planning, Warehouse, Safety, Medical and Regulatory affairs

• Other Quality Functions

• QMS document owners/authors

• Cross-site

• Global Functions: Regulatory (PDR/PTR), PT Development, EU QP, TPLs and GxP Supplier Management.

• Quality, Manufacturing, Engineering, Planning, Warehouse etc. of Contract Giver

Who you are:

Education/Qualifications

• Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent education level)

• Graduate or higher-level Degree is preferred

• Experience (may vary depending on site size/scope)

5 or more years’ work experience in the pharmaceutical or related industry

3 or more years’ experience in a commercially licensed GMP facility Knowledge/Skills/Competencies

• Professional knowledge of Quality System and QA principles, practices and standards for the pharmaceutical industry

• Rich knowledge of cGMP relevant to the pharmaceutical industry

• Knowledge of pharmaceutical, biotechnology or medical device related product operations including local and international quality regulations.

• Project management skills

• Demonstrate good verbal and written communication skills in English

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.