Associate Principal - RBQM; Drug Development

ASSOCIATE PRINCIPAL – CLINICAL QUALITY, OPERATIONS & RISK MANAGEMENT

ZS Associate Principals are senior leaders who combine deep industry expertise with strategic consulting, client leadership, and business development. They serve as trusted advisors to Life Sciences clients, helping shape clinical development strategies, modernize operating models, and accelerate digital transformation across Clinical Operations, Quality, and Risk Management.

We are seeking an experienced Clinical Quality, Operations, and Risk Management leader with extensive expertise in Risk-Based Quality Management (RBQM), clinical trial quality, regulatory compliance, and AI-enabled clinical operations. The ideal candidate will bring significant sponsor and/or CRO leadership experience, strong consulting skills, and a proven ability to build lasting executive relationships while driving growth for both clients and ZS.

• Serve as a trusted advisor to executive stakeholders across Clinical Operations, Clinical Quality, Data Management, Biostatistics, Medical, Regulatory, and Digital organizations.
• Lead strategic client engagements focused on Clinical Quality, RBQM, centralized monitoring, clinical operations transformation, data review and monitoring (including medical, safety, and statistical review), and digital innovation.
• Shape enterprise RBQM strategies, governance frameworks, centralized monitoring capabilities, and Quality Management Systems aligned with evolving regulatory expectations.
• Advise clients on implementing ICH E6(R3), ICH E8(R1), Quality by Design (QbD), Quality Risk Management (QRM), and modern clinical quality frameworks.
• Drive the design and implementation of AI-enabled clinical operations, workflow automation, and advanced analytics to improve trial quality, efficiency, and oversight.
• Lead cross-functional risk assessment activities, including Critical-to-Quality (CtQ), Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), Risk Assessment Categorization Tool (RACT), and centralized monitoring strategies.
• Advise clients on inspection readiness, GCP compliance, audit response, CAPA management, and enterprise quality governance.
• Partner with Clinical Operations and Data organizations to define oversight metrics, risk dashboards, operational KPIs, and AI-enabled decision support capabilities.
• Guide the development of next-generation clinical operating models, SOPs, governance processes, and quality frameworks across sponsor and CRO organizations.
• Represent ZS as an industry thought leader through conference presentations, publications, client workshops, and participation in organizations such as DIA, PHUSE, ACRO, SCDM, and Trans Celerate.
• Develop and strengthen executive client relationships that drive long-term strategic partnerships and business growth.
• Identify new consulting opportunities, contribute to proposal development, and support business development across Clinical Development and R&D.
• Mentor and coach consulting teams, helping build organizational capabilities across Clinical Quality, Clinical Operations, RBQM, AI, and advanced analytics.

• 15+ years of leadership experience within sponsor organizations, CROs, consulting firms, or clinical technology companies.
• Deep expertise in Clinical Operations, Clinical Quality, Risk-Based Quality Management (RBQM), centralized monitoring, and GCP Quality Management Systems.
• Extensive experience implementing ICH E6(R3), ICH E8(R1), Quality by Design, and modern risk-based clinical trial methodologies.
• Demonstrated experience leading enterprise RBQM programs, centralized monitoring organizations, and quality transformation initiatives.
• Strong understanding of clinical development technologies including CTMS, EDC, RBQM platforms, data visualization tools, AI-enabled workflow platforms, and clinical analytics solutions.
• Experience developing Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), CtQ frameworks, protocol and site risk assessments, and centralized monitoring methodologies.
• Experience leading inspection readiness activities, regulatory audits, CAPA development, and quality governance programs.
• Strong understanding of AI…