Fractional Executive Leadership

    BiggsB provides embedded, part-time executive leadership for regulated organizations that need senior compliance, quality, validation or AI governance leadership without a full-time hire. Fractional leaders own strategy and outcomes while building the team and systems that will carry the function forward.

    Discuss Your Project

    Who this is for

    • Growth-stage and PE-backed companies that need mature compliance leadership
    • Organizations between permanent hires or building a function for the first time
    • Companies deploying AI in healthcare, clinical research or regulated data environments

    When clients call us

    • A senior quality or compliance role is vacant
    • The business is growing faster than its compliance function
    • The board or investors need clear risk reporting
    • An inspection, audit or financing event needs senior ownership

    What the engagement covers

    • Fractional Compliance Officer: compliance strategy, governance, board-level risk reporting and inspection readiness across FDA, GxP, HIPAA, HITRUST, GDPR and SOX-regulated environments
    • Head of Computer System Validation: Part 11 and Annex 11 compliance, risk-based validation (CSA / GAMP 5) and validation of AI-enabled systems
    • Head of Quality Assurance: QMS build and remediation, CAPA governance, audit defense and vendor oversight
    • Chief of AI & Compliance: AI governance, model risk management and AI regulatory strategy

    Deliverables

    • Function strategy and 90-day plan
    • Governance cadence and risk reporting for leadership
    • Prioritized remediation and capability roadmap
    • Hiring support and handover plan for a permanent leader

    How we approach it

    1. Step 1

      Stabilize

      Take ownership of urgent risks, commitments and stakeholder reporting.

    2. Step 2

      Build

      Put the policies, processes and team structure in place.

    3. Step 3

      Transition

      Support recruitment and hand over to a permanent leader when ready.

    Service boundaries. Time commitment and decision authority are agreed in writing at the start of every fractional engagement.

    Questions about Fractional Leadership

    What does fractional leadership involve?

    A senior practitioner takes on an executive role for an agreed portion of each week, owning the function's strategy and results, attending leadership meetings and directing the team, without a full-time hire.

    When is fractional quality leadership appropriate?

    It suits organizations that need senior judgment now but do not yet need, or cannot yet attract, a full-time executive, including during growth, leadership transitions or inspection preparation.

    Related services

    Next step

    Discuss your fractional leadership project

    Tell us what you are trying to achieve. A senior practitioner will reply to discuss scope, timing and whether BiggsB is the right fit.

    Discuss Your Project