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Digital Pharmaceutical Manufacturing & Enterprise Technology Lead

International Business Machines Corp

  • San Francisco, CA
  • 3 days ago

    Highlights

    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. 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).

    Numbers & Facts

    LocationSan Francisco, CA
    IndustryComputer/IT Services
    Company Size10,000 employees or more
    Year Founded1911
    Websitehttp://www-03.ibm.com/employment/us/

    Description

    Introduction

    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.

    Your role and responsibilities

    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.

    Required education

    Bachelor's Degree

    Required technical and professional expertise

    • 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,

    Preferred technical and professional experience

    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)

    ABOUT BUSINESS UNIT

    IBM Consulting is IBM's consulting and global professional services business, with market leading capabilities in business and technology transformation. With deep expertise in many industries, we offer strategy, experience, technology, and operations services to many of the most innovative and valuable companies in the world. Our people are focused on accelerating our clients' businesses through the power of collaboration. We believe in the power of technology responsibly used to help people, partners and the planet.

    YOUR LIFE @ IBM

    Joining Anderon means helping shape a company at a formative stage. In a field where breakthrough ideas become dependable technologies, how we work matters. Our people stay curious, welcome feedback, and approach complex challenges with focus and personal responsibility. As part of the IBM group, eligible Anderon employees also have access to IBM benefits and programs. Explore the details below.

    Anderon's team provides world-class quality, trust, and technical excellence. You'll reflect these values and contribute to the culture that supports our growth.

    Few companies get to define an industry. At Anderon, you will. So come join us and pioneer quantum manufacturing.

    ABOUT IBM

    Anderon is America's most advanced pure-play quantum foundry, accelerating the future of quantum computing. Based in Albany, New York, we are creating a US-based manufacturing capability for quantum wafers, laying the foundation for scaling breakthrough quantum technologies.

    IBM is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, neurodivergence, age, or other characteristics protected by the applicable law. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

    OTHER RELEVANT JOB DETAILS

    IBM offers a competitive and comprehensive benefits program. Eligible employees may have access to:

    • Healthcare benefits including medical & prescription drug coverage, dental, vision, and mental health & well being
    • Financial programs such as 401(k), cash balance pension plan, the IBM Employee Stock Purchase Plan, financial counseling, life insurance, short & long- term disability coverage, and opportunities for performance based salary incentive programs
    • Generous paid time off including 12 holidays, minimum 56 hours sick time, 120 hours vacation, 12 weeks parental bonding leave in accordance with IBM Policy, and other Paid Care Leave programs. IBM also offers paid family leave benefits to eligible employees where required by applicable law
    • Training and educational resources on our personalized, AI-driven learning platform where IBMers can grow skills and obtain industry-recognized certifications to achieve their career goals
    • Diverse and inclusive employee resource groups, giving & volunteer opportunities, and discounts on retail products, services & experiences

    We consider qualified applicants with criminal histories, consistent with applicable law.

    This position was posted on the date cited in the key job details section and is anticipated to remain posted for 21 days from this date or less if not needed to fill the role.

    IBM will not be providing visa sponsorship for this position now or in the future. Therefore, in order to be considered for this position, you must have the ability to work without a need for current or future visa sponsorship.

    The compensation range and benefits for this position are based on a full-time schedule for a full calendar year. The salary will vary depending on your job-related skills, experience and location. Pay increment and frequency of pay will be in accordance with employment classification and applicable laws. For part time roles, your compensation and benefits will be adjusted to reflect your hours. Benefits may be pro-rated for those who start working during the calendar year.

    This position is eligible for participation in an IBM Sales Incentive plan. Actual incentive opportunity will be based on performance and the eligible Target Incentive, as addressed in the applicable plan, all of which is subject to change. The compensation range listed for this position is the IBM Reference Salary that is used when you are not actively participating in a sales plan. Your actual base pay plus incentive opportunity will be determined by the Incentive Plan assigned to you.

    About Company

    At IBM, you don’t need a degree to shape the future. Just bring your skills—and your passion. To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate.

    Not just to do something better, but to attempt things you've never thought possible. To lead in this new era of technology and solve some of the world's most challenging problems. Let’s get to work.

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