Digital Pharmaceutical Manufacturing & Enterprise Technology Lead

A career in IBM Consulting is built on long-term client relationships and close collaboration worldwide. You'll work with leading companies across industries, helping them shape their hybrid cloud and AI journeys. With support from our strategic partners, robust IBM technology, and Red Hat, you'll have the tools to drive meaningful change and accelerate client impact. At IBM Consulting, curiosity fuels success. You'll be encouraged to challenge the norm, explore new ideas, and create innovative solutions that deliver real results. Our culture of growth and empathy focuses on your long-term career development while valuing your unique skills and experiences. Seeking a Digital Pharmaceutical Manufacturing & Enterprise Technology Lead senior technology executive and client business development leader to serve as a trusted advisor and the face of IBM to Pharma/Biotech manufacturing clients. The successful candidate brings 15+ years of experience leading enterprise-wide digital transformation in regulated pharmaceutical, biopharmaceutical, and biotech manufacturing environments. The role partners with senior operations, quality, and technology leaders to align technology strategy. In this role, you are a seasoned pharma and biotech manufacturing consultant who pairs deep domain and technical expertise with executive presence. You communicate with clarity and authority, lead through influence, and are equally effective in a boardroom, a design workshop, or on the manufacturing floor. Clients see you as a partner who understands their science, their regulators, and their business. Your responsibilities include: Shape the client's digital manufacturing vision. Define and execute AI-enabled digital manufacturing roadmaps that unify ERP, MES, LIMS, QMS, EHS, serialization, advanced planning, and shop-floor/edge systems into a connected, validated operating model governed by FDA and GMP requirements. Lead greenfield and brownfield transformation. Provide architectural leadership for new manufacturing facility buildouts and modernization of existing plants — spanning clinical and commercial operations and end-to-end systems integration. Modernize the technology foundation. Guide the transition to secure, resilient hybrid cloud architectures that support mission-critical, GxP-regulated operations without compromising data integrity or validated state. Advise at the sr. stakeholder level. Translate business and regulatory priorities into architectural vision, solution guidance, and investment-grade roadmaps that resonate with both technical and business audiences. Grow the relationship and the business. Originate, shape, and expand business opportunities — identifying where IBM capabilities create measurable client value and leading solutioning through to proposal. Build lasting trust. Establish and sustain strong relationships with the client's leadership, product owners, and cross-functional stakeholders, engaging credibly with both business and technology leaders. This job can be performed from anywhere in the U.S. Pharma/Biotech Manufacturing Operations: Deep knowledge of pharma/biotech manufacturing processes — including batch management, tech transfer, and scale-up from clinical to commercial. Strong MES expertise; Preferred: hands-on experience with Körber PAS-X MES Suite or Rockwell PAS-X Quality Management in Regulated Industries: Strong knowledge of end-to-end quality processes: deviations, CAPA, change control, investigations, batch disposition and release, supplier quality, audits/inspections, and Annual Product Quality Review (APQR) Product Lifecycle Management (PLM / PLK): Knowledge of PLM and PLK practices across formulation, specifications, bill of materials, and recipe management Regulatory Submissions & Quality Platforms: Experience with pharmaceutical regulatory submission and lifecycle processes: eCTD submissions, post-approval variations, regulatory change impact assessment, and IDMP data standards. Preferred: experience with Veeva Vault RIM, including integration with manufacturing and quality systems Understanding of serialization and track-and-trace requirements GxP, Validation & Data Integrity: Strong command of GxP regulations and computerized system validation (CSV) Enterprise & Shop-Floor Integration: Experience architecting integrated landscapes across ERP (e.g., SAP S/4HANA), MES, LIMS, QMS, EHS, advanced planning and scheduling, historians, and OT/edge systems AI & Data Foundations: Experience designing and delivering AI-driven manufacturing solutions, including establishing a foundational semantic data layer — encompassing ontologies, knowledge graphs, contextualized manufacturing data models, unified namespace, and data fabric patterns Manufacturing Domain Expert, Strong MES expertise; Preferred: hands-on experience with Körber PAS-X MES Suite, Understanding of serialization and track-and-trace requirements, GxP, Greenfield manufacturing facility buildouts experience is a big plus — experience spanning digital plant design, system selection, integration architecture, and commissioning/qualification/validation (C&Q/CQV) through operational readiness (strong plus) United States Project Management Hybrid Professional San Francisco, US San Francisco (0147) International Business Machines Corporation