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Job description
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
At Roche, our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society.
The RBQM Strategic Lead embeds risk-based quality management across cross-functional study teams to protect participant safety and data integrity; from protocol development through study conduct, you will act as a strategic advisor and mentor, helping teams define what is Critical to Quality (processes and data), establish review strategies, and share cross-program insights to prevent recurring risks and drive study success..
Key Responsibilities
Strategic Leads will be allocated on a disease area basis to support study teams with the following:
Identifying what is Critical to Quality
Risk Assessment discussion
Critical Data and Processes selection
Set up of risk control strategies and functional plans
Help study team members understand how to use the risk assessment and selection of critical data to drive their functional review strategies using both existing systems and the future approach of the IQRMP
Regular involvement in the ongoing risk assessments during the study conduct, including advising on mitigation strategies
Feedback loop to protocol design and RBQM set up for new studies in the same area to support learnings within and across DA
Key Competencies :
Good Clinical Practice (GCP)
Clinical Operations
Critical thinking
Change mindset
Problem-Solving
Communication
Stakeholder engagement and management
Influencing and negotiation
Inclusive leadership
Strategic decision making (ensure we focus on the work that adds value)
Competency utilizing AI and AI agents
Who are you
You'll be a core team member within the RBQM Centre of Excellence, based at one of our main sites. We are seeking a highly motivated and committed professional who brings:
Strong experience in Good Clinical Practice (GCP) & Clinical Operations.
Cross-functional (Clinical Science, Data Sciences, Clinical Operations, Safety Science or Quality) knowledge in clinical study management and execution.
Experience participating in cross-functional teams
Create an inclusive environment by acknowledging all dimensions of diversity and actively practicing Allyship
Ability to facilitate decision making, communicate and maintain a position to support the RBQM strategy
Expertise in RBQM processes, including awareness of industry strategy and direction, knowledge and understanding of ICH E8 and ICH E6 requirements.
Understanding of data-driven analytics and the ability to translate data insights into action.
Proficiency in root cause analysis, and development of corrective and preventive actions.
Proven critical thinking and problem solving skills using coaching methods.
Quality communication, relationship management and influencing skills.
Willingness to ask challenging questions and comfortable with difficult conversations.
The Cyntegrity White Belt Course on RBQM fundamentals is a strong preference.
Please kindly provide a cover letter alongside your CV. The interview process will consist of a screening one-way video interview, followed by a case study presentation.
We look forward to your application!
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Welwyn. 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.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.
Worksite address
south san francisco, CA, 94083, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.