Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die 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 aQuality 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 aSenior 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.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
