RBQM Strategic Lead

Roche • Mississauga, ON

8d • Hybrid

About 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.

Requirements

• 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.

Nice To Haves

• The Cyntegrity White Belt Course on RBQM fundamentals is a strong preference.

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

Benefits

• A healthier future drives us to innovate.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed