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 PositionAs a Quality Solutions Lead within our PDQ, you will work within a team of experts and collaborate with peers within the function and across the organization to identify, design and execute fit-for-purpose quality solutions, driving the delivery and sustainability of a robust and regulatory compliance Quality Management System (QMS) ，drive quality culture and implement in China. You will ensure the timely completion of quality solution deliverables and partner with business/stakeholder, overseeing and providing technical expertise in the delivery of high quality solutions to deliver regulatory compliant and high quality processes. You will also contribute to functional, cross-functional, enterprise-wide or external initiatives that shape our technical landscape, business and healthcare environments. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to evolve the way we design and deliver the QMS and to enable accelerated delivery medicines and access for our patients.
As a Quality Solutions Lead, you will be accountable to implement and deliver quality solutions to demonstrate confidence in our QMS in order to accelerate regulatory review and approval for medicines and integrated healthcare solutions. You will partner with cross-functional teams and external partners and work with considerable independence. Contributes to the continual improvement of internal processes and system support.
As a Senior Quality Solutions Lead, you will be accountable to deliver quality solutions through designing innovative/new/efficient quality solutions to demonstrate confidence in our QMS in order to accelerate regulatory review and approval for medicines and integrated healthcare solutions. We will look to you to contribute to complex cross-functional or cross chapter squads taking a leading role and navigating situations within the QMS landscape.
Primary Responsibilities and Accountabilities:
QUALITY SOLUTIONS: Deliver quality solutions which enable Roche to meet regulations/standards /HA expectations, in an efficient and effective way. Activities may include, but are not limited to:
○ Regulatory Intelligence - proactively analyzes regulatory landscape and assesses impact of emerging and changes to existing regulations to Roche processes.
○ Process design & procedures development - partners with business to design processes, maximally leveraging automation and system workflow, development of performance metrics/signals/evidence-based oversight measures.
○ Process deployment - partners with the business to implement processes, including delivery of training/performance solutions to demonstrate qualification and competency of business to execute processes.
○ Continuous Improvement - drives process improvement activities, leveraging Quality Analytics & Insights and strong decision making for and with Global Process Owners; partner with the business to proactively identify, analyze and improve existing processes and create solutions to optimize performance, meet best practice standards or improve quality and the user experience for customers and end-users.
QMS EXCELLENCE: Demonstrate process integrity to health authorities
○ Develop process strategies and proactively manage timelines to ensure successful oversight and delivery of quality solutions, including the implementation and adoption of new technologies and solutions that drive efficiency and cost savings.
○ Continuously improve internal process/tools/systems driving process effectiveness and efficiencies.
○ Supports/manages workflow of Quality processes, including performance indicators, data accuracy, operational metrics, documentation, ticketing tools/queries.
STAKEHOLDER MANAGEMENT: Proactively engage with stakeholders across the business to influence their understanding of decisions made to sustain/evolve the QMS. Inform stakeholders of status of key deliverables and act on changing milestones.
VENDOR MANAGEMENT: Oversee development of quality solutions service agreements with vendors ensuring use of standards, fit-for-purpose quality solutions. Management/oversight of contractors/ service providers.
SUPPORT ANALYSES: Partner with stakeholders to drive quality insight needs and design quality solutions. Demonstrate a strong understanding of the process requirements, workflows and regulatory requirements in clinical development, safety/pharmacovigilance, medical device, digital health and personalized healthcare/PHC areas. Performs trending analysis of data to identify patterns and potential systemic findings.
FUNCTIONAL EXCELLENCE: Collaborate and contribute to functional/cross-functional initiatives or goals to promote new ways of working, including emerging technologies.
TECHNICAL CONSULTANT: Offer guidance and advice to peers within the function and related communities, to key stakeholders the QMS and quality solutions to ensure high quality process design and delivery. Seamlessly applies multiple methodologies (business process improvement, adult learning, project, change and knowledge management) as needed to lead the creation of systems and process solutions for highly complex initiatives. Deliver on solutions as needed.
Professional and Technical Requirements Education:
● Masters, Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience
Minimum Qualifications:
● Meets the behaviors & competencies described in RCC for individual contributors
● Experienced professional with demonstrated applied knowledge of regulatory requirements in GCP，addition with pharmacovigilance (GVP)/device Quality expertise and operation experience will be preferred ; including a broad understanding of product development and global expectations of Health Authorities in the area of pharmaceutical development.
● Strategic insights analysis
● Quality data storytelling
● Critical thinking
● Influence and impact
● High learning agility
● Proactive risk-based approach
● Data Analytics experience
Reports to: PDQ China Head
Other (e.g. Travel):
Travel: up to 20%
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Shanghai. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.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.
Skills Required
- Master's or Bachelor's degree in scientific or quality-related field
- Demonstrated applied knowledge of regulatory requirements in GCP and pharmacovigilance
- Experience in product development and understanding of health authority expectations
- Strong analytical and data storytelling skills
- High learning agility and proactive risk-based approach
- Experience in quality data analytics
Roche Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.
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Retirement Support — U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
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Leave & Time Off Breadth — Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
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Healthcare Strength — Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.
Roche Insights
What We Do
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).
