About Kevin Shea

Compliance-Focused Technology Consultant for Life Sciences Teams Navigating Growth & Complexity

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Purpose

My core goal is simple: to make technology truly serve the mission of life sciences. Every system, every SOP, every implementation, and every validation project I take on is ultimately about one thing—supporting the success of scientific research and the people it’s meant to help. Whether it’s early-stage discovery, clinical trial execution, or post-market surveillance, I focus on aligning technology with the realities of how work gets done in regulated environments.

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Bridging Business and Technology

That alignment requires more than just technical implementation. It means translating between business teams and technology vendors—two groups that often don’t share a common vocabulary or a clear understanding of each other’s priorities. I help bridge that gap. Whether it’s aligning system behavior with SOPs, clarifying requirements across stakeholders, resolving conflicts between process and platform, or surfacing risks before they turn into delays, my role is to ensure both sides stay coordinated and focused on what matters: enabling better research through better systems.

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Approach & Expertise

I’ve spent over 25 years working at the intersection of life sciences technology, compliance, and operational execution. My consulting practice is centered on helping life sciences companies select, implement, and validate technology that meets regulatory expectations without slowing down innovation.

Key areas of focus include: • Compliance-aware technology implementation • Validation strategies that balance rigor with efficiency • Quality systems that scale with organizational maturity • Workflow, data flow, and systems analysis • Migration, integration, reporting, and user documentation • Risk-based assessment of ROI and total cost of ownership • Change management and team enablement

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Philosophy

I believe that specialization creates value. By focusing deeply on the implementation and compliance challenges unique to life sciences, I deliver insights and solutions that actually work in the real world—not just in documentation. My goal is to reduce friction, increase clarity, and ensure that systems are adopted, understood, and sustainable.

As one client put it:

“Kevin’s ability to translate between technical requirements and operational reality saved us months of rework and significantly improved user adoption.”

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Client Relationships

Roughly 80% of my work comes through referrals or repeat engagements. I take on projects selectively to ensure each client gets the attention and expertise it deserves. That sometimes means saying no to opportunities outside my wheelhouse—a discipline that ultimately serves my clients and protects the quality of the outcomes.

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Looking Forward

I’m currently developing a structured approach to compliance strategy for early-stage life sciences companies—particularly those navigating the shift from discovery into clinical development. These teams often need quality systems that are both inspection-ready and lightweight enough to keep pace with innovation. That’s where I come in.

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Connect

I’m always open to exploratory conversations—especially with teams navigating complex decisions around system implementation, compliance, and validation.

Email: kfshea@driftpin.com
LinkedIn: linkedin.com/in/kfshea
Long-form writing: driftpin.substack.com ⸻

“In a complex world, expertise is defined by what you choose not to do.”