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Leadership

The First Quality Leader I Ever Knew: Lessons from Mom
Leadership ► May 5, 2026

The First Quality Leader I Ever Knew: Lessons from Mom

In medical devices and pharmaceuticals, we talk a lot about quality systems, CAPAs, and regulatory compliance. But after thirty-five years in this industry, from the clinical lab to the boardroom, I’ve realized that the most...

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Why Being a Woman Quality Leader in MedTech & Pharma is a Superpower
Leadership ► March 17, 2026

Why Being a Woman Quality Leader in MedTech & Pharma is a Superpower

In medical devices and pharmaceuticals, quality isn’t just a department; it’s the foundation of patient safety and organizational trust. For over thirty-five years, my work from the clinical lab to the boardroom has taught me...

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The Quality Compass: How Leadership Styles Forge a Culture of Excellence in Pharma and MedTech
Leadership ► December 15, 2025

The Quality Compass: How Leadership Styles Forge a Culture of Excellence in Pharma and MedTech

In pharmaceuticals and medical devices, “quality” is more than a department, it’s the core of the industry. It’s the difference between a life-saving drug and a catastrophic recall, between a trusted medical implant and a...

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Beyond the SOP: Why Your Leadership Style is Your Most Critical Quality Tool
Leadership ► October 21, 2025

Beyond the SOP: Why Your Leadership Style is Your Most Critical Quality Tool

In medical device and pharmaceutical manufacturing, we pride ourselves on precision. Our processes are validated, our Standard Operating Procedures (SOPs) are detailed, and our quality systems are designed to eliminate variability. Yet, despite these robust...

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International Women’s Day – This One’s for the Girls!
Leadership ► March 7, 2025

International Women’s Day – This One’s for the Girls!

Each year, the world dedicates a day to reflect on the incredible power of women leaders and the influence they wield. This year it was March 8th – International Women’s day. This photo, taken during...

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Confessions of a Quality Queen
Leadership ► July 16, 2024

Confessions of a Quality Queen

It’s my birthday month, and as we typically do , I have taken time to be introspective about where I have been and where I am going.  From 2001 to 2020, I was the Head...

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Recent Posts

  • The First Quality Leader I Ever Knew: Lessons from Mom
  • The FDA’s New Playbook: Preparing for Inspections Under the QMSR
  • Why Being a Woman Quality Leader in MedTech & Pharma is a Superpower
  • The Compliance Challenge of BioTech in Winter Sports
  • Bridging the ISO 13485 to QMSR Gap: The Top 3 Overlooked Issues

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