Quality Business Analysis
19 hours ago
Philadelphia, PA, United States
ZS Associates
Full-time
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ZS Insights & Analytics Quality PracticeZS 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.
ZS's Insights & Analytics group partners with clients to design and deliver solutions to help them tackle a broad range of business challenges. Our teams work on multiple projects simultaneously, leveraging advanced data analytics and problem-solving techniques. Our recommendations and solutions are based on rigorous research and analysis underpinned by deep expertise and thought leadership.
Within our Quality practice, we work at the intersection of Quality domain expertise, business transformation, data, digital, and AI. Our work spans global Quality process and operating model redesign, predictive product risk solutions, intelligent investigations, and AI-enabled compliance capabilities. We focus on building the next generation of enterprise Quality capabilities for pharmaceutical and life sciences companies.
What You'll Do
In this role, you will lead Quality business analysis, delivery, and project execution on client facing workstreams across complex transformation initiatives. You will work with clients to understand current-state processes, pain points, systems, controls, and data needs; define future-state requirements; and coordinate across Quality SMEs, product teams, data scientists, designers, and engineers to deliver scalable solutions.
Lead workstreams and teams & conduct stakeholder interviews and document Quality processes, pain points, controls, systems, and data requirementsBring an outside-in perspective to identify gaps in existing QMS capabilities and develop innovative solutionsSupport future-state process design, QMS transformation, Quality analytics, and AI-enabled use casesAnalyze Quality data, develop business and functional requirements, support testing, and prepare client deliverablesManage day-to-day project execution and coordinate across business, Quality, data, and technology teamsConvert client delivery insights into reusable frameworks, data models, analytical components, playbooks, and implementation assetsSupport proposals, demonstrations, solution workshops, effort estimation, accelerators, and thought leadershipGuide and mentor project team members and contribute to building future Quality Consultants and solution leadersWhat You'll BringBachelor's or Master's degree in life sciences, engineering, pharmacy, biotechnology, data science, information systems, or a related fieldAt least 5 year of experience in life sciences across Quality, QMS, manufacturing, laboratory operations, and/or consultingStrong working knowledge of at least two Quality processes such as deviations, CAPA, complaints, change control, risk management, supplier quality, or QMS implementation and configurationExperience leading teams and supporting large-scale Quality transformation or technology-enabled initiativesAbility to identify process and QMS capability gaps / enterprise application whitespaces and define solutions using workflow, data, analytics, AI, GenAI, and other digital capabilitiesExperience navigating at least one major QMS platform, such as Veeva Vault Quality, TrackWise, SmartSolve/SmartQMS, ComplianceQuest, ETQ, or similarStrong analytical skills with exposure to Excel, SQL, Power BI, Python, GenAI, or similar toolsExperience translating business needs into process, data, system, and functional requirementsUnderstanding of GxP, data integrity, CSV/CSA, validation, and traceability requirements for digital and AI-enabled Quality solutionsStrong stakeholder management, communication, and problem-solving skillsAbility to work across Quality, business, product, data, and technology teamsFluency in EnglishClient-first mentalityIntense work ethicCollaborative spirit and problem-solving approachAdditional SkillsStrong communication skills, both verbal and written, with the ability to structure complex concepts clearlyAbility to simplify technical and Quality concepts into practical frameworks and client-ready recommendationsStrong attention to detail and a quality-focused mindsetClient service orientation and ability to build credibility with senior stakeholdersAbility to work effectively within global, cross-functional teamsHigh motivation, strong work ethic, mat
ZS's Insights & Analytics group partners with clients to design and deliver solutions to help them tackle a broad range of business challenges. Our teams work on multiple projects simultaneously, leveraging advanced data analytics and problem-solving techniques. Our recommendations and solutions are based on rigorous research and analysis underpinned by deep expertise and thought leadership.
Within our Quality practice, we work at the intersection of Quality domain expertise, business transformation, data, digital, and AI. Our work spans global Quality process and operating model redesign, predictive product risk solutions, intelligent investigations, and AI-enabled compliance capabilities. We focus on building the next generation of enterprise Quality capabilities for pharmaceutical and life sciences companies.
What You'll Do
In this role, you will lead Quality business analysis, delivery, and project execution on client facing workstreams across complex transformation initiatives. You will work with clients to understand current-state processes, pain points, systems, controls, and data needs; define future-state requirements; and coordinate across Quality SMEs, product teams, data scientists, designers, and engineers to deliver scalable solutions.
Lead workstreams and teams & conduct stakeholder interviews and document Quality processes, pain points, controls, systems, and data requirementsBring an outside-in perspective to identify gaps in existing QMS capabilities and develop innovative solutionsSupport future-state process design, QMS transformation, Quality analytics, and AI-enabled use casesAnalyze Quality data, develop business and functional requirements, support testing, and prepare client deliverablesManage day-to-day project execution and coordinate across business, Quality, data, and technology teamsConvert client delivery insights into reusable frameworks, data models, analytical components, playbooks, and implementation assetsSupport proposals, demonstrations, solution workshops, effort estimation, accelerators, and thought leadershipGuide and mentor project team members and contribute to building future Quality Consultants and solution leadersWhat You'll BringBachelor's or Master's degree in life sciences, engineering, pharmacy, biotechnology, data science, information systems, or a related fieldAt least 5 year of experience in life sciences across Quality, QMS, manufacturing, laboratory operations, and/or consultingStrong working knowledge of at least two Quality processes such as deviations, CAPA, complaints, change control, risk management, supplier quality, or QMS implementation and configurationExperience leading teams and supporting large-scale Quality transformation or technology-enabled initiativesAbility to identify process and QMS capability gaps / enterprise application whitespaces and define solutions using workflow, data, analytics, AI, GenAI, and other digital capabilitiesExperience navigating at least one major QMS platform, such as Veeva Vault Quality, TrackWise, SmartSolve/SmartQMS, ComplianceQuest, ETQ, or similarStrong analytical skills with exposure to Excel, SQL, Power BI, Python, GenAI, or similar toolsExperience translating business needs into process, data, system, and functional requirementsUnderstanding of GxP, data integrity, CSV/CSA, validation, and traceability requirements for digital and AI-enabled Quality solutionsStrong stakeholder management, communication, and problem-solving skillsAbility to work across Quality, business, product, data, and technology teamsFluency in EnglishClient-first mentalityIntense work ethicCollaborative spirit and problem-solving approachAdditional SkillsStrong communication skills, both verbal and written, with the ability to structure complex concepts clearlyAbility to simplify technical and Quality concepts into practical frameworks and client-ready recommendationsStrong attention to detail and a quality-focused mindsetClient service orientation and ability to build credibility with senior stakeholdersAbility to work effectively within global, cross-functional teamsHigh motivation, strong work ethic, mat