Associate Principal - RBQM (Drug Development)

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS.
ASSOCIATE PRINCIPAL - CLINICAL QUALITY, OPERATIONS & RISK MANAGEMENTZS 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.

What You'll Do:

• 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 TransCelerate.
• 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.

What You'll Bring:

• 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 applications within Clinical Development, including intelligent automation, AI governance, and agent-assisted clinical workflows.
• Experience designing SOPs, governance frameworks, operating models, and business processes supporting clinical quality and operations.
• Proven experience leading complex, cross-functional consulting engagements involving executive stakeholders.
• Demonstrated success building trusted client relationships and expanding strategic consulting engagements.

Preferred Qualifications

• Recognized industry expertise demonstrated through publications, conference presentations, industry working groups, or regulatory collaborations.
• Active participation in industry organizations such as DIA, PHUSE, ACRO, SCDM, TransCelerate, or Avoca.
• Experience leading enterprise digital transformation initiatives across Clinical Development.
• Experience with advanced analytics, AI, machine learning, and modern clinical technology ecosystems.
• Experience supporting global regulatory inspections across FDA, EMA, MHRA, PMDA, and other health authorities.

Willingness to travel to other global offices as needed to work with client or other internal project teams
How you'll grow:

• Cross-functional skills development & custom learning pathways
• Milestone training programs aligned to career progression opportunities
• Internal mobility paths that empower growth via s-curves, individual contribution and role expansions

Perks & Benefits:
At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well-being, financial future, time away, and professional development. With robust skills-building programs, multiple career progression paths, internal mobility, and a deeply collaborative culture, you'll have the opportunity to do meaningful work, expand your capabilities, and thrive as part of a global community. For details on total rewards in United States , visit ZS US office locations | Where we work | ZS .
Hybrid working model:
We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Travel:
Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
Considering applying?
At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems-the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. Learn more about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive.
If you're eager to grow, contribute, and bring your unique self to our work, we encourage you to apply.
ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.
Work Authorization:
This position is not eligible for visa sponsorship. Candidates must have authorization to work in the United States that does not now or in the future require employer sponsorship.
To complete your application:
An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.
NO AGENCY CALLS, PLEASE.
Find Out More At:
www.zs.com