Case Studies -  Delivery Leadership For High-Risk Digital Programs

A multinational biotech company launched a global initiative to standardize MES batch records in order to reduce upgrade costs and lower long-term total cost of ownership. Three years into the program, execution had become fragmented, and the initiative was at risk of missing a critical milestone: batch record readiness for the production startup of a newly built manufacturing facility.

Role:
I stepped in to lead delivery at a critical point in the program, with responsibility for stabilizing execution, reducing risk, and ensuring go-live readiness in a GMP-regulated environment.

Approach:

• Execution focus: Identified and eliminated competing priorities that were diluting throughput and putting the go-live at risk.

• Structural simplification: Reduced reliance on manual, error-prone work by introducing automation where it had the highest impact.

• Delivery discipline: Established clear ownership, execution cadence, and real-time visibility into progress for both the team and executive stakeholders.

• Team leadership: Re-centered the delivery team around a single, high-stakes objective and maintained momentum under intense timeline pressure.

Outcomes:

• Delivered standardized batch records in time for the new facility’s production startup.

• Restored confidence among executive sponsors and plant leadership through transparent, predictable execution.

• Reduced delivery effort and ongoing maintenance burden through automation.

• Put the broader global rollout back on track to achieve its targeted cost and efficiency gains.

A global manufacturer running a highly customized MES environment faced escalating risk as a major platform upgrade approached. Years of accumulated customizations had made upgrades costly, slow, and increasingly fragile, raising concerns around operational continuity, validation effort, and long-term total cost of ownership.

Role:
I led the program to de-risk the upgrade, owning technical strategy, stakeholder alignment, and execution planning in a GMP-regulated environment.

Approach:

• Risk-based assessment: Led a structured review of all customizations to determine which could be replaced with standard platform functionality and which were truly business-critical.

• Technical strategy ownership: Defined the de-customization strategy, setting clear principles to reduce risk and cost  while preserving essential business capabilities

• Team leadership: Directed cross-functional teams through de-customization and upgrade activities, maintaining focus, quality, and momentum under regulatory constraints

Outcomes:

• Reduced MES customizations by more than 50%.

• Significantly improved speed, cost, and quality of future upgrades.

• Lowered long-term total cost of ownership and reduced ongoing validation and maintenance burden.

A pharmaceutical company acquired a new manufacturing facility in the United States to expand capacity in support of upcoming clinical trials and commercial launch. To meet demand and scale manufacturing volumes, the site required rapid digitization of core business processes while maintaining compliance and readiness.

Role:
I led delivery of the site digitization program, with responsibility for technical strategy, execution leadership, and cross-functional alignment under aggressive timelines.

Approach:

• Technical strategy & governance: Defined the digitization roadmap and IT governance model, securing senior leadership approval to ensure alignment with launch and scale objectives.

• Execution leadership: Directed implementation and rollout of core manufacturing systems, including MES and warehouse management, coordinating across IT, manufacturing, and quality.

• Tech transfer under pressure: Led the technology transfer from an existing facility, balancing speed with reliability and compliance.

• Focus on readiness: Kept the program tightly aligned to manufacturing scale-up milestones rather than technology delivery alone.

Outcomes:

• Delivered MES and warehouse management capabilities ahead of schedule.

• Enabled the site to scale manufacturing capacity in support of clinical and commercial demand.

• Established a digital foundation that reduced launch risk and supported future growth.