Strategic RBQM Lead — Drive Risk‑Based Quality

Roche; Mississauga; On-site; CAD 131,000 - 169,000; Full time

Job summary

Roche is seeking a RBQM Strategic Lead to embed risk-based quality management across cross-functional study teams, protecting participant safety and data integrity from protocol development through study conduct.

You will act as strategic advisor, mentor, and facilitator for decision making, defining Critical to Quality, and shaping risk control strategies, with experience in GCP and RBQM.

Qualifications

• Strong experience in Good Clinical Practice (GCP) and Clinical Operations.
• Cross-functional knowledge in clinical study management and execution.
• Experience participating in cross-functional teams.
• Create an inclusive environment and advocate Allyship.
• Ability to facilitate decision making and support RBQM strategy.
• Expertise in RBQM processes and ICH E8/E6 familiarity.
• Understanding of data-driven analytics and translating insights into action.
• Proficiency in root cause analysis and CAPA development.
• Proven critical thinking and problem-solving using coaching methods.
• Quality communication and stakeholder management skills.
• Willingness to engage in challenging conversations.
• Preference for Cyntegrity White Belt RBQM fundamentals.

Responsibilities

• Identify what is Critical to Quality.
• Lead risk assessment discussions.
• Select Critical Data and Processes.
• Set up risk control strategies and functional plans.
• Explain how risk assessments guide reviews using current and future RBQM approaches.
• Participate in ongoing risk assessments during study conduct and advise mitigations.
• Provide feedback to protocol design and RBQM setup for new studies.

Skills

GCP & Clinical Ops

RBQM strategy

Cross-functional work

Data analytics

Root cause analysis

Communication

Stakeholder mgmt

Inclusive leadership

AI in RBQM

Decision facilitation

Job description

Roche is seeking a RBQM Strategic Lead to embed risk-based quality management across cross-functional study teams, protecting participant safety and data integrity from protocol development through study conduct.

You will act as strategic advisor, mentor, and facilitator for decision making, defining Critical to Quality, and shaping risk control strategies, with experience in GCP and RBQM.