Senior Director, Business Process Transformation

MESO SCALE DIAGNOSTICS, LLC.Rockville, MD
Onsite

About The Position

The Senior Director of Business Process Transformation is responsible for architecting and advancing MSD's digital thread — the governed, end-to-end flow of product, process, service and quality data connecting R&D, engineering, manufacturing, quality, regulatory, supply chain, and commercial operations — and for leading the enterprise-wide redesign of the business processes that span this value chain. This role is focused on the business architecture, process excellence, and transformation outcomes the enterprise platforms are purchased to enable. The Senior Director serves as a strategic thought partner to executive leadership, translating long-range business objectives into an integrated process roadmap, defining target-state operating models, leading cross-functional change initiatives, and governing value realization. Working in close partnership with Enterprise Platforms, Engineering, Quality, Manufacturing, Supply Chain, and Commercial leadership, the Senior Director sets process architecture standards, drives continuous improvement, and measures transformation outcomes against quantifiable business KPIs.

Requirements

  • Bachelor's degree in Engineering, Business, Computer Science, or a related discipline, or equivalent work experience; advanced degree (Master’s or MBA or PhD) preferred.
  • A minimum of fifteen years of progressive experience in business process transformation, enterprise/business architecture, or digital transformation leadership, preferably in a regulated manufacturing environment.
  • A minimum of five years leading enterprise-scale transformation programs that span multiple business functions and enterprise platforms.
  • Proven experience defining and executing digital thread or model-based enterprise strategies that link product definition to manufacturing execution to service and commercial feedback.
  • Demonstrated working knowledge of PLM, ERP, and MES platforms — specifically Siemens Teamcenter, Oracle JD Edwards (JDE), and SAP S/4HANA — and how they integrate to enable the digital thread. Deep hands-on configuration ownership is not required; strong fluency in the capabilities, integration patterns, and data models is required.
  • Demonstrated experience leading Lean, Six Sigma, or business process management initiatives that have delivered measurable operational and financial outcomes.
  • Demonstrated experience leading enterprise change management for multi-year transformation programs, including executive stakeholder alignment and adoption strategy.
  • Implementation experience working across multiple departments with customers at various organizational levels.
  • Deep understanding of digital thread principles, model-based enterprise concepts, and end-to-end process architecture in a regulated manufacturing context.
  • Recognized thought leader with a future-focused perspective on Industry 4.0, AI-enabled process automation, closed-loop quality, digital twin, and the evolving role of enterprise platforms in life sciences.
  • Expert knowledge of PLM, ERP, and MES business domains — including product lifecycle, engineering change, planning, procurement, manufacturing execution, quality, regulatory, and order-to-cash — with the fluency to translate across them without owning platform configuration.
  • Strong business architecture and process modeling skills, including BPMN, value stream mapping, capability mapping, and target operating model design.
  • Demonstrated mastery of Lean, Six Sigma, and business process management methodologies and the ability to select and sequence them appropriately.
  • Superior leadership skills with demonstrated ability to influence across functions, lead through ambiguity and change, and establish accountabilities without direct authority.
  • Strong organizational change management capability, including stakeholder engagement, communications strategy, training design, and adoption measurement.
  • Organizational, program, and priority management skills for planning, executing, and following up on multi-year transformation portfolios in order to meet established deadlines and value-realization targets.
  • Demonstrated ability to develop executive-grade business cases, measure benefits realization, and hold transformation programs accountable to quantified KPIs.
  • Demonstrated critical thinking and analytical skills, as well as the ability to handle complex situations and demonstrate sound judgment and problem-solving.
  • Excellent communication and storytelling skills with the ability to organize, present, and articulate ideas both verbally and in writing, including the ability to influence at the executive level and simplify complex transformation concepts for non-technical audiences.
  • Ability to effectively communicate risks, dependencies, and results that impact transformation timelines, business outcomes, and compliance posture.

Nice To Haves

  • Certification in Lean Six Sigma (Black Belt or higher), business process management (e.g., CBPP), enterprise architecture (e.g., TOGAF), business architecture (e.g., CBA), or change management (e.g., Prosci ADKAR) is preferred; PMP is a plus.
  • Consultant experience on implementations for Life Science organizations preferred.

Responsibilities

  • Defines and owns MSD's digital thread vision, strategy, and reference architecture — the governed end-to-end flow of product, process, service, and quality data connecting design, engineering, manufacturing, quality, regulatory, and commercial functions.
  • Serves as a thought leader and future-focused advisor to executive leadership on digital thread, Industry 4.0, model-based enterprise, AI-enabled process automation, closed-loop quality, digital twin, and composable business capabilities.
  • Leads end-to-end business process transformation programs spanning the PLM, ERP, and MES value chains, including product design release, engineering change, item and BOM management, planning, procurement, manufacturing execution, inventory, quality, regulatory, and order-to-cash.
  • Builds and maintains MSD's enterprise process architecture — capability maps, value streams, end-to-end process models, and target-state operating models — that inform investment decisions and transformation sequencing.
  • Partners with the Enterprise Platforms function that owns the configuration, operation, and technical support of Siemens Teamcenter (PLM), Oracle JD Edwards & SAP S/4HANA (ERP), and MES, QMS platforms; translates process requirements into platform capability requirements and holds the integration teams accountable.
  • Leads strategic business process reengineering initiatives using Lean, Six Sigma, business process management (BPM), and design thinking methods to deliver measurable operational and commercial outcomes.
  • Directs the business case, roadmap, and value realization for enterprise transformation programs — including stage-gate governance, outcome KPIs, benefits tracking, and executive reporting.
  • Builds and leads a high-performing team of process architects, business analysts, and transformation leaders; develops functional, analytical, and change leadership capabilities across the team and broader organization.
  • Collaborates with Engineering, Manufacturing, Supply Chain, Quality, Regulatory, Commercial, and Finance leadership to co-design integrated processes and translate business outcomes into capability requirements.
  • Ensures comprehensive documentation of process architecture, target-state designs, transformation playbooks, and governance artifacts.
  • Collaborates with Enterprise Platforms, Software Engineering, IT Infrastructure, and Cybersecurity teams to align process designs with secure, scalable, and compliant system implementations.
  • Stays current with emerging transformation methodologies, enterprise architecture frameworks, and industry benchmarks relevant to life sciences and regulated manufacturing.
  • Ensures that transformation artifacts — process designs, change documentation, training materials, validation evidence — meet GxP, 21 CFR Part 11, ISO 9001, and ISO 27001 expectations in partnership with Quality, Regulatory and regulated services functions.
  • Defines and tracks digital transformation and process excellence KPIs — cycle time, first-pass yield, process automation rate, data quality, user adoption, cost-to-serve, and transformation ROI — and drives data-informed improvement.
  • Specific duties may vary depending upon departmental requirements.

Benefits

  • medical, dental, and vision coverage, along with prescription benefits.
  • 401(k) plan with company matching
  • flexible spending accounts
  • company-paid short- and long-term disability insurance
  • group life and accidental death and dismemberment insurance.
  • paid vacation, paid sick leave, paid holidays, and paid parental leave
  • employee assistance program.
  • fitness club membership contribution
  • pet insurance
  • identity theft protection
  • home and auto insurance discounts
  • optional supplemental life insurance.
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