Selected Success Stories

01. FDA Commitment Project Delivery

Inherited a high-risk, high-visibility project with an FDA response commitment date after four consecutive project manager turnovers. Within one month, redefined the project plan, clarified roles and responsibilities, and rallied a cross-functional team of 25 (including three vendors) from "storming" to "performing." Delivered new business processes, SOPs, training, and a technology solution on time and under budget, eliminating the client's compliance risk entirely.

02. Quality Maturity Assessment

Delivered a comprehensive quality maturity gap assessment for a pre-IND biotech, presenting findings and a strategic roadmap directly to the executive leadership team. Provided actionable recommendations that shaped the company's quality infrastructure strategy ahead of first IND submission.

03. Clinical QA Governance & PMO

Partnered with Clinical QA VP to implement a strategic plan and program management framework across a portfolio of 20+ projects and 6 senior directors -establishing KPIs, tracking mechanisms, and governance structures that created visibility and accountability across the organization.

04. IT Roadmap Execution

Led the full execution of an IT roadmap (delivered earlier by a fractional CIO), implementing best practice IT Governance & SOPs (including AI tool evaluation, selection and governance), managing MSP vendor selection, working cross functionally on system selection & implementations. Enabled the organization to build and scale its IT infrastructure to support expanding clinical programs, taking the company from early-stage operations to a more mature, governed IT environment.

05. Global Enterprise QMS Harmonization

Led the rollout of standardized enterprise quality system procedures and processes across North America, Europe, and Asia Pacific, collaborating with local country teams to drive a unified approach to quality while maintaining compliance with regional regulations and eliminating inconsistencies.

06. Commercial Ops & Sales Alignment

Led the assessment, redesign, and implementation of a bi-annual sales alignment and roster management process for a global commercial-stage biotech, identifying inefficiencies and implementing an integrated electronic solution to replace manual, paper-based workflows. Delivered accurate master data to downstream systems - directly improving incentive compensation accuracy across the field organization and eliminating uncontrolled data management practices at scale.