In this episode of The MedTech Talent Lab, Mitch Robbins sits down with Elena Mack, Chief Quality Officer at Sanisure, to discuss her career journey and insights into the world of quality and regulatory leadership in the medical device industry. With over 25 years of experience, Elena has held key executive roles at companies like Olympus, BD, and Teva Pharmaceuticals. Now, as part of Sanisher, she is leading the charge to build and maintain a world-class quality program for the bioprocessing and biomanufacturing sectors.

Elena shares her early career experiences, including her shift from medical technology to microbiology and how she got started at Wyeth in a regulatory compliance role. She reflects on pivotal moments in her career, including taking on a leadership role as a director at ACUPAC and the invaluable lessons she learned about leadership, delegation, and the importance of empowering her team.

Throughout the conversation, Elena also delves into the challenges of being a quality executive, emphasizing the responsibility of ensuring that quality is a shared value across all levels of an organization. She highlights the critical importance of having a robust quality system and talks about the ongoing efforts at Sanisher to move from ISO 9001 to ISO 13485, aiming to meet the highest standards of quality required by their customers.

With her unique perspective on quality as a critical but often underappreciated function in the industry, Elena offers valuable insights into the role of quality professionals and how they can drive real impact within their organizations.

Key Takeaways:

The importance of leadership by example and empowering teams.
The challenges and rewards of stepping into executive roles and delegating responsibilities.
The need for robust quality systems in bioprocessing and biomanufacturing, especially in meeting regulatory standards.
Elena’s personal connection to quality through her experiences with her son’s health challenges.

Links: