Real Scenarios

Scenario 1 — Gene Therapy Scale-Up

A global pharma organization was preparing the industrialization of a new Gene Therapy product in a dedicated facility. Multiple critical functions — quality, analytical, manufacturing, material management and regulatory — needed to be coordinated simultaneously under significant time pressure.

Omnia Project can support the coordination of cross-functional workstreams, ensuring alignment across teams and timely progress toward industrialization readiness milestones.

Scenario 2 — Performance Framework from Shop Floor to Senior Leadership

A large biotech manufacturing site was preparing for Health Authority audits to obtain its Site Manufacturing License. The organization needed a structured performance tracking system that could connect operational teams with senior leadership decision-making.

Omnia Project can design and implement performance dashboards covering Safety, Quality, Delivery, Engagement, and Cost (SQDEC), introduce daily huddle routines and visual management boards, and support KPI definition from shop floor level up to Senior Leadership, ensuring full visibility and audit readiness.

Scenario 3 — Business Process Mapping for Tech Transfer and Inspection Readiness

A pharmaceutical site undergoing Tech Transfer and Validation activities needed to map and standardize its core business processes to align with global strategy and prepare for regulatory inspection.

Omnia Project can facilitate Business Process Mapping sessions across any organizational function, ensuring process clarity, accountability, and alignment with corporate standards.

Scenario 4 — PMO Setup and Governance for Global Projects

A global pharma organization needed to establish a structured project portfolio governance across multiple international sites in the US, EU, and Asia. Leadership required clear visibility on project status, priorities, and risks.

Omnia Project can support the setup of governance frameworks, facilitate leadership workshops, drive strategic planning and goal setting, and ensure cross-functional alignment across geographies.