Redesigning Global Process Ownership for a Top-10 Pharmaceutical Company
A global pharmaceutical company's quality systems organization lacked the governance infrastructure to match its operational scale. Acquis designed and operationalized a Global Process Ownership (GPO) framework that replaced fragmented accountability with a tiered, measurement-driven governance model deployable across 40+ countries.
Governing quality at global scale
The Global Quality Systems Organization within a top-10 pharmaceutical company governs compliant trial execution, patient safety, clinical integrity, site management, and product manufacturing for all study programs in more than 40 countries. Its mandate extends across the full enterprise quality system — change control, CAPA, documentation, training, audit and inspection readiness, and complaint management — and touch every function from R&D through commercial operations. At the time of the engagement, the organization's governance footprint covered approximately 40,000 to 50,000 stakeholders, roughly 5,000 systems, and operations spanning more than 40 countries.
When ownership exists on paper but not in practice
The organization's quality system governance grew organically alongside its global footprint. The company maintained process playbooks, governance councils, and compliance metrics, but accountability remained diffuse, decision rights lacked clarity, and ownership stayed nominal. Central functions lacked visibility into what was happening across the network in real time.
The consequences were operational. When issues surfaced at a clinical trial site or manufacturing facility, unclear ownership and the absence of early warning signals forced the most disruptive response available: pause enrollment, pause manufacturing, pause data flow. Leadership had no systematic global view of where risk was building, no way to triage emerging issues before they forced a shutdown, and no consistent model for who owned what across regions and functions.
The organization needed a governance model that could establish clear, end-to-end process ownership across clinical and manufacturing operations, shift quality management from reactive compliance reporting to proactive risk identification, and standardize decision-making without adding bureaucracy. The model had to adapt to processes at different levels of maturity and risk, and internal teams had to be able to own and extend it after the engagement ended.
Designing global process ownership
Acquis partnered with the organization's quality leadership to design and operationalize a Global Process Ownership (GPO) governance framework — a structured model for assigning, scaling, and sustaining process ownership across a complex global quality network. The work moved through four interconnected workstreams.
Current state assessment and gap analysis
Acquis mapped documentation, governance forums, ownership structures, and metrics across the organization, distinguishing where ownership was genuinely active from where it was structural but hollow. That diagnostic pinpointed the governance gaps creating the highest risk exposure and set the direction for everything that followed.
Tiered GPO governance model
From the assessment findings, Acquis designed a fit-for-purpose governance model with explicit roles, decision rights, and escalation paths. A decision framework determined when a process warranted full, medium, or light governance, calibrated to prevent the over-engineering that frequently stalls enterprise governance initiatives. The model established accountability across five ownership tiers, from global executive sponsors to local process owners.
Leading indicator framework
The Acquis team worked with the quality team to move measurement beyond lagging compliance metrics into operationalized leading indicators. The team identified specific indicators, assigned point values, defined scoring logic, and tied each indicator to business outcomes. The resulting framework gave the organization a mechanism for proactive risk triage, surfacing problems while there is still time to intervene before operations pause. In most quality organizations, leading indicator conversations stall at conceptual agreement. This engagement moved past that threshold into indicators the organization can score, track, and act on.
Process maturity assessment and improvement pathway
Finally, Acquis developed an interactive process maturity review (PMR) tool designed for global deployment. The assessment evaluates processes across key attributes, including data, technology, process design, and people, through a two-part structure. The first phase is a rapid triage with focused questions to help process owners identify which attributes are falling short of target and where to concentrate effort. The second phase goes deeper. For areas below target, the tool surfaces diagnostic questions that guide teams through root cause analysis, feeding directly into a process maturity improvement plan (PMIP).
To validate the full framework could scale without ongoing external dependency, Acquis created a deployment roadmap, onboarding toolkits, and communications assets to help internal teams adopt and extend the GPO model independently across regions and functions.
A governance model built to scale
The engagement delivered a standardized yet flexible GPO governance model that scales across processes of varying maturity and risk. Clear accountability now spans five ownership tiers, from global executive sponsors to local process owners, replacing nominal ownership with active governance and defined decision rights.
Leading indicators tied to business outcomes give leadership visibility into where risk is building and where resourcing gaps exist. The process maturity assessment tool connects diagnosis directly to structured improvement planning, giving the organization a repeatable mechanism it can deploy globally.
The framework is designed to work across heterogeneous country settings and apply to any therapeutic area in a diverse pipeline. Deployment assets including a rollout roadmap, onboarding toolkits, and communications materials work to ensure internal teams can extend the model to new regions and functions on their own timeline.
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