Meet Allison Kazlauskas, Manager of Quality Compliance at Sequoia Biotech Consulting. With over 12 years of experience in Good Manufacturing Practice (GMP), medical device, and research development, Allison brings a wealth of expertise to the Sequoia team. She is certified as a lead auditor for ISO 9001:2015 and 13485:2016, further demonstrating her commitment to upholding excellence in quality and compliance within the life science sector.

At Sequoia, Allison and her team specialize in developing phase-appropriate quality systems to fit the unique needs of each of our life science partners. Their approach centers around fostering a quality culture that encourages both individual empowerment and team collaboration, ensuring that the systems they help develop for our clients are not only adaptable but also scalable as their businesses grow and evolve.

When asked about key lessons learned from her experience in leading quality system implementation projects and the critical factors for success, Allison shared the following insights:

One thing that I’ve learned about quality systems is that they are not one-size-fits-all programs. Ensuring that your quality objectives align with your organization’s overall business strategy is the key to success. Without proper organization and foresight, your quality system may be developed with a narrow focus and fail to grow effectively with future changes in regulations, industry standards, or internal processes. This oversight can result in frustration, low compliance rates, and delays in product launches. An effective quality system should be flexible enough to adapt to evolving requirements without requiring extensive rework.