Shantel Kelly
Enterprise Quality Leader | Quality Strategy and Governance
- Role
- Senior Director, Quality Assurance at Kaleo
- Location
- Richmond, VA, US
- LinkedIn followers
- 500 followers
About Shantel Kelly
I lead quality as an enterprise control function in regulated biopharmaceutical and medical device environments, with accountability spanning research, clinical development, and commercialization. My focus is designing quality systems that govern risk, withstand regulatory scrutiny, and scale with the business. I have held global and enterprise quality leadership roles, including serving as Global Head of Quality Assurance across multi-site operations and leading quality systems and compliance functions within complex organizations. I architect operating models that translate regulatory expectations into durable systems, clear decision rights, and consistent execution. I am trusted to bring clarity where risk, speed, and compliance intersect - using quality as a mechanism for protecting patients, preserving supply, and sustaining organizational credibility.
Experience
Senior Director, Quality Assurance
Oct 2024 — Present
As Head of Quality Assurance at Kaléo, I own the quality, compliance, and inspection-readiness strategy across regulated operations. I serve as the final authority for quality risk decisions, regulatory direction, and system governance, ensuring patient safety, supply continuity, and sustained compliance.I design and govern scalable quality operating systems that translate regulatory expectations into durable business execution, with full accountability for inspection readiness, risk management, and quality system performance. I regularly advise senior leadership on system health and risk exposure to support informed, company-level decisions.
Education
Cornerstone University
Bachelor’s Degree, Bachelor of Science
2005 — 2009
Lake Michigan Community College
Biology/Biological Sciences, General
1996 — 1998
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