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Ernst & Young

Global professional services: consulting, assurance, tax

Life Sciences Supply Chain Manufacturing Ops & AI Transformation Delivery Senior Manager

Operations & Supply Chain ConsultingConfirmed live in the last 24 hours
Full-timeRemote in USA$150.4k - $390.5k

About the Job

Requirements

  • A bachelor's degree in engineering, life sciences, manufacturing, supply chain, information systems, business, or a related discipline.
  • At least 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.
  • Experience leading senior stakeholders and multidisciplinary teams across business, functional, data, and technology workstreams.
  • Experience translating manufacturing requirements into process, system, data, integration, security, and technical requirements, with traceability through testing and deployment.
  • Practical understanding of GxP manufacturing and the quality, documentation, change-control, and data-integrity considerations relevant to digital solutions.
  • Ability to travel as needed based on business and role requirements; travel can range from 80–100%.
  • Strong knowledge of Life Sciences manufacturing processes and the relationship between production, quality, laboratory operations, engineering, and supply.
  • Techno-functional leadership that earns the confidence of plant teams while providing clear direction to architects, engineers, developers, data scientists, and cybersecurity specialists.
  • Working knowledge of industrial data and integration patterns, including OPC UA (IEC 62541), MQTT/Sparkplug, APIs, historians, asset and batch contextualization, and unified-namespace approaches, and the ability to evaluate how these patterns support secure, reliable data exchange across OT and enterprise systems.
  • Sound judgment about where analytics or AI can improve a workflow, what evidence is needed to support its use, and where human review and quality oversight must remain.
  • Executive communication, structured problem-solving, facilitation, negotiation, and the ability to make decisions under ambiguity.
  • Commercial and delivery discipline across estimates, staffing, engagement economics, change control, risk management, and value realization.

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, depending 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.
  • Create clarity and alignment across distributed teams, motivate people through complex delivery challenges, and maintain accountability without becoming the bottleneck for decisions.
  • Develop Managers and delivery teams, contribute reusable methods and lessons learned, and identify appropriate follow-on opportunities with account teams.

Desired Qualifications

  • Experience with drug substance, drug product, biologics, sterile manufacturing, medical devices, or clinical-to-commercial scale-up.
  • Experience leading multi-site deployments, greenfield or brownfield plant modernization, or manufacturing technology-transfer initiatives.
  • Implementation experience with one or more MES/MOM platforms, electronic batch records and eDHRs, recipe management, connected-worker tools, industrial analytics, or manufacturing data platforms.
  • Familiarity with ISA-88/IEC 61512, ISA-95/IEC 62264, OPC UA/IEC 62541, and OT cybersecurity practices informed by ISA/IEC 62443 and NIST SP 800-82. Exposure to IEC 61131-3, IEC 61499, CESMII i3X, O-PAS, or SiLA 2 is a plus where relevant to the client environment.
  • Familiarity with Process Analytical Technology (PAT) and continuous-improvement practices, and their application to manufacturing analytics, process performance, quality, and operational decision-making.
  • Experience with computer system validation or risk-based computer software assurance, as applicable to the systems and regulated products involved.
  • Experience applying AI or advanced analytics to manufacturing or quality workflows with appropriate model governance, monitoring, and human oversight.
  • A master's degree or relevant program-management, operational-excellence, cloud, data, or manufacturing-technology certification.

About the Company

Ernst & Young

Global professional services: consulting, assurance, tax

EY (Ernst & Young) provides professional services at a global scale, offering consulting, assurance, tax, and transaction advisory services. It serves clients across industries such as technology, media, real estate, hospitality, and construction. Instead of selling a single product, EY works with clients through tailored engagements where cross-disciplinary teams analyze challenges, design strategies, perform audits, help with tax planning, and assist with mergers or divestitures. What sets EY apart is its worldwide reach and integrated service model, industry-specific expertise, and focus on responsible business practices like sustainability, cybersecurity, and workforce flexibility. EY’s goal is to help organizations improve performance, manage risk, and achieve sustainable growth while building a better working world.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Boston, MA
Founded
1991

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