Digital readiness & operating model design · GxP operations

Digital ambition breaks in the operating model first.

Not in the technology. In the process, the governance, and the ownership underneath it. IMC Strategy Group assesses where you actually stand across manufacturing, supply chain, quality, and technical development — then builds what has to change.

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Readiness assessed across four pillars Manufacturing · Supply chain · Quality · Technical development
Pillar 01

Process

Maturity, standardization, and the workflows digital capability will actually run on.

Pillar 02

Governance

GxP AI governance, validation approach, model oversight, and audit readiness.

Pillar 03

Data & technology

Architecture, data quality, integration, and the platforms carrying the load.

Pillar 04

Operating model

Ownership, decision rights, capability structure, and how the work gets run.

The problem

Everyone is being told to move faster on AI. Almost no one has the foundation to do it inside a GxP footprint.

Boards want AI. Regulators want evidence. Operations teams are caught between them — asked to deploy quickly on processes that were never standardized, data that was never governed, and an operating model that has no owner for any of it.

The failure mode is predictable. Pilots that never scale. Governance written after deployment. Validation approaches invented per project. Capability built in one function that no one else can use.

IMC Strategy Group works from inside that footprint — manufacturing, supply chain, quality, and technical development — not from the enterprise IT layer above it. That is where the constraints live, and it is where the work has to start.

Two engagements

Assess what's real.
Then build the machine.

The diagnostic stands on its own. Most clients use it to decide what to build next.

Engagement one

Digital Readiness Diagnostic

Know where you actually stand before you scale.

Duration
3–4 weeks
Investment
Scoped per engagement
Format
Fixed scope, fixed fee

A structured assessment of digital and AI readiness across the regulated operations footprint. We interview across functions, review the artifacts that actually govern the work, and map maturity against what your ambition requires.

Assessed
  • Process maturity and standardization across manufacturing, supply chain, quality, and technical development
  • Governance model, including GxP AI oversight, validation approach, and audit readiness
  • Data architecture, quality, and integration across operational systems
  • Operating model, ownership, decision rights, and capability structure
You receive

A readiness assessment across all four pillars, a prioritized roadmap with sequencing and dependencies, a governance framework recommendation, and an executive-ready readout for board or leadership review.

Engagement two

Operating Model & Network Build

We don't hand you a roadmap. We build the machine.

Duration
Typically 3–6 months
Investment
Scoped per engagement
Format
Embedded, hands-on

Hands-on design and build of the operating model, external network, and planning capability required to scale from clinical through commercial — working alongside your team, not adjacent to it.

Scope areas
  • Operating model and organizational design for regulated operations
  • CDMO and external manufacturing network strategy
  • Supply planning and S&OP capability build-out
  • Third-party risk and supplier governance
  • Clinical-to-commercial supply transition and launch readiness
  • Digital and data capability, including centers of excellence
You receive

A designed and implemented operating model, standing capability your team owns, and the governance to run it — not a deck describing what someone else should do.

Who this is built for

Organizations scaling into
complexity they haven't hit yet.

Emerging & growth-stage biotech

Moving from clinical to commercial, where the external network and planning capability that worked at Phase 2 will not survive launch.

Private equity & venture

Operating partners who need an honest read on portfolio company operations — and someone who can go in and fix what the diagnostic finds.

Established pharma & medtech

Technical operations and supply organizations under pressure to deploy AI and digital capability without breaking compliance.

About

25 years building what others only advise on.

  • PhD, Analytical Chemistry · MS, Biochemistry · BS, Biophysics
  • Certified Lean Six Sigma Black Belt
  • Top 100 Women in Supply Chain, 2025
  • Direct FDA and EMA regulatory engagement

Imara Michelle Charles, PhD, has spent 25 years inside regulated operations — from hands-on cGMP manufacturing and supply planning at a contract development organization serving emerging biotech, through asset-level CMC strategy, external manufacturing networks, and enterprise supply chain leadership at one of the world's largest biopharmaceutical companies.

Most recently she served as Chief of Staff to the EVP of Global Product Development & Supply and Head of Digital Transformation, working across an 11,000-person global manufacturing, supply chain, quality, and technical development organization.

Her work has spanned the establishment of GxP-compliant AI governance, the integration of a $74B acquisition, a $700M strategic CDMO partnership, and the design of digital and data centers of excellence. The through-line is consistent: strategy that survives contact with a shop floor, an audit, and a launch date.

"Strategy without execution is just a document. Execution without strategy is just activity. My work lives in the space between."

What that expertise does

Translating technology investment

Turning platform and data spend into measurable supply chain performance and resilience — enterprise data platforms, advanced planning systems, and AI-enabled operations that hold up under audit.

Accelerating operational transformation

Operating model redesign, digital transformation, and post-acquisition integration across global manufacturing and supply networks — including governance frameworks and cross-functional change leadership.

Delivering P&L impact

Strategic sourcing, CDMO network optimization, and operating model design that translate operational complexity into sustained financial value and organizational scalability.

$74BAcquisition integration leadership across manufacturing & supply
$700MStrategic CDMO partnership structured and governed
12Commercial launches across biologics, cell therapy & small molecules
99%OTIF delivered across U.S. markets
Insights

The Operating Room

Where supply chain, data, and P&L leadership meet execution. Monthly.

AI & governance

Why supply chain data fabric is the real AI governance problem

Governance debates focus on models. The failure almost always starts upstream, in the data layer nobody owns.

 CMC strategy

What growth-stage biotechs get wrong about CMC

Early CMC decisions ripple through to launch timelines and submissions long after anyone remembers making them.

 External networks

Negotiating with CDMOs when you have no leverage

Small companies don't win on spend. They win on being the easiest customer to say yes to.
Contact

Start a conversation.

IMC Strategy Group works with a small number of clients at a time. Every engagement begins with a discovery conversation — no cost, no obligation.

Emailhello@imcstrategygroup.com
LinkedInlinkedin.com/company/imc-strategy-group-llc
LocationMorristown, NJ · Clients worldwide
ResponseWithin 24–48 business hours