When full-time isn’t the right fit: The benefits of a Fractional Head of QA

For early-stage biotech companies or lean clinical teams, bringing on a full-time Head of Quality Assurance (QA) may not always make sense.

Limited budgets, evolving pipelines, and shifting priorities make flexibility essential. But even at the earliest stages of development, strategic QA leadership is critical to ensure compliance and inspection readiness, build strong systems, and avoid costly missteps.

That’s why many companies utilize G&L Scientific’s Fractional Head of QA model.

A Fractional Head of QA offers senior-level Quality leadership on a part-time or project-based basis. This role provides all the strategic oversight of a full-time QA lead without the permanent headcount or overhead.

At G&L, our fractional QA leaders bring deep experience and invaluable direct insight. They define and oversee QA strategy from day one, helping clients establish a quality foundation that is phase-appropriate and compliant.

They also guide the design and rollout of the Quality Management System (QMS), ensuring it scales with the client’s development program while staying right-sized for their specific resources.

In addition, they play a critical role in inspection readiness by preparing teams, reviewing documentation, CAPA (Corrective and Preventive Action) support, and managing responses if regulatory findings occur. They provide advice and oversight across clinical, regulatory, and vendor activities, ensuring alignment and compliance throughout all operations.

Most importantly, they function as embedded partners, supporting both internal teams and external collaborators with practical, risk-based decision-making that drives progress without compromising quality.

Many clients avail of this service to build out their QA function without overcommitting to a full-time hire. It is a practical solution during early development, when resources may be limited but foundational systems still need to be in place.

In times of transition, such as leadership turnover or organizational change, a fractional QA lead can provide stability, maintain continuity, and support long-term planning. When teams face high-stakes milestones like IND submissions, site inspections, or clinical trial launches, fractional leadership ensures that quality oversight is always in place.

For companies experiencing rapid growth, this model helps extend internal capabilities while maintaining quality and compliance across functions.

G&L’s Fractional Head of QA service is part of our broader Product Development and Market Access Platform, which brings together QA, Regulatory, Clinical, and Market Access expertise under one roof.

To find out more about how G&L can support your team and your projects, click here.