With over two decades of relentless dedication to Quality Management in the biotechnology sector, spanning prominent roles in top-tier regulated companies across the USA, and Europe, I bring a unique blend of expertise that sets me apart.

My career has been defined by a mastery of international regulations and standards including FDA, GMP, EMA, ISO 13485, MDR (EU) 2017/745, and IVD (EU) 2017/746 ensuring that the products and processes meet and exceed the most stringent industry requirements.

I have successfully managed and helped design Quality Control Laboratories for more than 20 years, guiding teams to excel in quality assurance, audits, and product testing, all while maintaining strict compliance by promoting a Quality culture.

My expertise extends to global technology transfers, and product development while navigating the complexities of product clearance, launches, and releases in biopharma and medical device start-ups. I have personally handled external inspections and audits, certifications, and licensing from prestigious regulatory and notified bodies like the FDA, Spanish Health Agency (AEMPS), TUV, and BSI.

Beyond my technical proficiency, I am a proven change agent who fosters organizational health, engagement, and inclusion within high-performance teams. My ability to bridge cultural gaps and communicate effectively in English and Spanish empowers me to navigate international collaborations seamlessly.

In an industry where precision, compliance, and innovation are paramount, my track record speaks for itself. I am not just a Quality Management expert; I am a strategic partner committed to elevating your organization's performance, ensuring regulatory compliance, and fostering a culture of excellence and growth.

Let's collaborate to transform challenges into opportunities and drive your biotechnology endeavors towards unparalleled success.

Values: Lead by example, Science-based, Help improve patients quality of life, Team work