Senior Life Sciences Manufacturing AI Transformation Lead

EY; San Diego (CA); Remote; USD 188,000 - 390,000; Full time

Job summary

EY in the United States is seeking a Senior Manager to lead end‑to‑end Life Sciences manufacturing transformations, linking plant operations with enterprise data and systems. The role blends regulated plant-floor expertise with AI, automation and analytics to deliver measurable value in pharma, biotech and medical devices.

You’ll build trusted relationships with senior stakeholders across manufacturing, quality, IT/OT, engineering and supply, define programs from problem to value realization,

Qualifications

• Bachelor's degree in engineering, life sciences, manufacturing, supply chain, information systems, business, or a related discipline.
• 10+ years of relevant experience spanning Life Sciences manufacturing, manufacturing technology, operational excellence, industrial data and AI, technology consulting, or a related field.
• Experience leading complex manufacturing transformation or technology-enabled improvement initiatives in a pharmaceutical, biotechnology, medical-device, or comparably regulated environment.
• Experience delivering client-facing programs through design, implementation, deployment, and stabilization, with accountability for governance, resources, quality, financial performance, and risk.

Responsibilities

• Lead end-to-end Life Sciences manufacturing transformations, from assessment and mobilization through design, deployment, stabilization, and value realization.
• Build trusted relationships with senior manufacturing, quality, MS&T, engineering, supply chain, digital, and IT/OT stakeholders; establish governance and drive timely decisions.
• Translate priorities such as yield, throughput, right-first-time execution, deviation reduction, batch-cycle time, asset reliability, and supply continuity into practical workplans and outcome measures.
• Direct multidisciplinary teams across manufacturing process design, MES/MOM, automation, data engineering, AI, architecture, integration, quality, change management, testing, and deployment.
• Lead solution and process design for batch and discrete execution, electronic batch records, electronic device history records (eDHRs), recipes and routings, material and product genealogy, review by exception, maintenance, quality workflows, and plant performance management.
• Guide integration across MES/MOM, ERP, LIMS, QMS, historians, SCADA, DCS/PLC, asset-management systems, and relevant cloud or edge platforms.
• Establish trusted manufacturing data foundations through appropriate data models, asset and process context, master data, metadata, lineage, governance, and secure IT/OT connectivity.
• Shape analytics and AI use cases, such as process monitoring, predictive maintenance, deviation investigation support, digital twins, and decision support; assess their value, data readiness, workflow fit, and risks before scaling.
• Partner with client quality and validation teams to incorporate applicable GxP controls, data integrity, electronic-record requirements, change control, and risk-based assurance into delivery plans. The applicable controls will depend on the product, system, and intended use.
• Manage scope, schedule, budget, staffing, dependencies, quality, risks, issues, and contractual commitments; guide testing, cutover, training, adoption, and operational handover.
• Connect digital solutions to daily management, operational excellence, workforce capability building, and sustained process improvement.
• Ability to create clarity and alignment across distributed teams, motivate people through complex delivery challenges, and maintain accountability without becoming the bottleneck for decisions.
• People leadership and talent-development capability, including coaching, delegation, performance feedback, conflict resolution, succession planning, and building teams with the right mix of functional, technical, and industry skills.
• Develop Managers and delivery teams, contribute reusable methods and lessons learned, and identify appropriate follow-on opportunities with account teams.

Skills

Techno-functional leadership

Regulated manufacturing

Executive communication

Data and analytics fluency

GxP knowledge

Education

Bachelor's degree in engineering or life sciences

Tools

MES/MOM platforms

ERP

LIMS

QMS

SCADA

DCS/PLC

Cloud platforms

Job description

EY in the United States is seeking a Senior Manager to lead end‑to‑end Life Sciences manufacturing transformations, linking plant operations with enterprise data and systems. The role blends regulated plant-floor expertise with AI, automation and analytics to deliver measurable value in pharma, biotech and medical devices.

You’ll build trusted relationships with senior stakeholders across manufacturing, quality, IT/OT, engineering and supply, define programs from problem to value realization,