Quality Process Lead

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.

Principle Roles & Responsibilities / Accountabilities

Quality Risk Management

• Act as the QRM process as well as system owner, maintain and improve QRM process. Lead Quality Risk Management and provide relevant tools and expertise in PT China.

• Act PT China risk management community key responsible person, coordinate and oversees the PT risk management process within PT China to ensure compliance with relevant GMP/GSP regulations and Roche Group standards related to risk management, communicate consolidated risks and activities to senior management regularly.

• Ensure potential product and patient risks are systematically assessed, controlled, reviewed and communicated, and risk management activities are documented appropriately.  

• Site contact person with global QRM network, and BDO (Business Data Owner).

Quality Monitoring & Metrics

• Through the MRoQ establish internal controls and rigorous governance frameworks to ensure consistent adherence to quality and compliance standards.

• Facilitate and coordinate Site Quality Council and Quality System Management Review, and support site requirements for quality system metrics reporting and data analysis.

• Strengthen management systems to provide actionable metrics and establish comprehensive, real-time quality processes.

Supplier Quality Management

• Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Roche and Health Authority audits, complex investigations and market complaints.

• Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements.

• Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate.

Other Responsibilities

• Support China Compliance activities.

• Support policy advocacy topics, related working groups and external interactions.

• Other activities assigned.

Qualification and Experience

Education/Qualifications

• Bachelor's Degree required (science, biology, biochemistry or bio engineering is preferred); Graduate or higher-level Degree is preferred.

• Science Bachelor degree or above.

• Pharmaceutical, Chemistry, Biochemistry, Bio-engineering or relevant disciplines.

Leadership Competencies

• Models Integrity

• Focus on value and customer

• Align for success

• Deliver results

• Learn for the future

Job Required Competencies

• 7 or more years' work experience in the pharmaceutical or related industry, MNC pharma preferred.

• 3 or more years' manufacturing or quality management experience in the pharmaceutical industry.

• Good knowledge of Quality System and Compliance principles, practices and standards for the pharmaceutical industry.

• Good knowledge of cGMP relevant to the pharmaceutical industry, knowledge of the local and international GMP regulations.

• Deep understanding of quality risks, importance of compliance, and escalation management

• Well communication skill and good accountability of problem solving.

• Good at English, listening, speaking, reading and writing.

• Good at office software: Word, Excel, Power Point.

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.