Associate Director, Risk Based Quality Management

Location: Remote within the United States

Salary: $169,222–$253,000 annually, plus incentive opportunity

Company

hirify.global develops pharmaceutical and healthcare solutions, with this role supporting global clinical trial operations and quality management.

What you will do

• Develop, govern, and optimize the risk-based quality management operating model, including frameworks, processes, tools, and performance metrics.
• Lead risk identification, evaluation, mitigation, and oversight across study, program, and portfolio levels.
• Oversee quality tolerance limits, key risk indicators, centralized monitoring, and analytical reviews of clinical and operational data.
• Drive process improvement, standardization, automation, analytics adoption, change management, and RBQM training.
• Provide strategic direction to Clinical Management, Data Management, Biostatistics, Quality Assurance, Safety, CROs, FSPs, consultants, and other vendors.
• Lead audit and inspection readiness, CAPA development, remediation, vendor performance oversight, and clinical operations budget monitoring.

Requirements

• Bachelor’s degree in life sciences or a related field; an advanced degree is preferred.
• At least 8 years of experience in the pharmaceutical or biotechnology industry, preferably in clinical or trial operations involving RBQM.
• Strong experience with risk-based quality management, centralized monitoring, clinical data analytics, and global clinical trials.
• Knowledge of ICH E6(R2/R3), ICH E8(R1), GCP, global regulatory expectations, clinical trial processes, operational risk, and data quality principles.
• Experience with RBQM tools, clinical systems, data visualization platforms, analytics dashboards, change leadership, and process transformation.
• Strong communication, facilitation, influencing, planning, analytical, problem-solving, and cross-functional collaboration skills; willingness to travel as required.

Culture & Benefits

• Collaborative work across Clinical Management, Data Management, Biostatistics, Quality Assurance, Safety, Finance, Procurement, and external partners.
• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided life, accidental death and dismemberment, short-term disability, and long-term disability insurance.
• Tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs.
• Focus on accountability, strategic thinking, patient and customer centricity, respectful collaboration, and professional development.