Risk-Based Quality Management Expert (Manager Equivalent) - Remote!

MaxisIT Inc. (Inc. 2003) is seeking an experienced and forward-thinking Risk-Based Quality Management Expert (REMOTE) to lead the implementation and execution of proactive, risk-focused quality oversight across global clinical studies. The scope encompasses implementation of enterprise RBQM strategies, standards, and initiatives to strengthen quality oversight and inspection readiness.

Your main accountabilities will be:

• Act as a Subject Matter Expert and Process Responsible for e.g. Protocol Deviations and Issue Management process
• Process Manager for the Protocol Deviations and Issue Management process, or other assigned RBQM-related processes as determined by business priorities
• Drive successful implementation, operation, and maturation of the Protocol Deviations and Issue Management process
• Facilitate cross-functional workshops to identify and document Critical-to-Quality (CtQ) factors, critical data, and critical processes.
• Lead and facilitate Risk Review Meetings (RRMs) and ensure comprehensive documentation of risk evaluations and decisions.
• Support the Process Owner in defining strategy and direction for the process, ensuring a simple, stable, compliant, and continuously improved process
• Update risk assessments based on protocol amendments, emerging signals, or changes to critical data and processes.
• Support program-level and organizational RBQM governance and oversight activities.
• Contribute to continuous improvement initiatives to enhance RBQM maturity and effectiveness across the organization.

Qualifications & Experience

• 10+ years of comprehensive clinical research experience, collaborating with global stakeholders
• Hands-on with clinical trial processes, data flows, and risk-based monitoring strategies.
• Proven expertise in implementing and successfully running RBQM frameworks.
• Excellent communication, stakeholder engagement, and cross-functional collaboration skills