RBQM Strategic Lead

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:

• 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
• Competency utilizing AI and AI agents

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 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.

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.

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.