R&D Quality 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.

The Position

As 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 Bachelors 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 GCPaddition 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%

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.