AssurX recently welcomed Stephanie Ojeda as its new Vice President of Product Management. From working in pharmaceutical labs to leading quality systems across biotech, medical device, and food & beverage, Ojeda has seen quality management from every angle.

We sat down with Ojeda to discuss her journey, the evolving landscape of quality management, and how AI is reshaping the future of compliance.

Tell us about your journey in quality assurance and how you went from working hands-on in QA functions to leading product management at AssurX.

My background is in chemistry, and I started my career very much on the doing side of quality. Working in the lab, working in QA, writing SOPs, running investigations, sitting through audits—essentially living inside of those systems every day.

Early on, I tried to be that person who bridged the gap between QA and operations. People would come to me when the process in the SOP didn’t line up with reality or when systems made it harder to do the right thing.

That experience pulled me deeper into the systems side of quality—building a QMS from the ground up, designing workflows, and turning regulatory requirements into something people can actually use.

As I moved from the lab to quality analyst, quality manager, then director of quality, I found myself energized not just by following processes but by designing them. I was constantly asking, why does this form look like that? Why is this SOP structured this way?

That spirit of continuous improvement naturally led me to the software side, and ultimately, to AssurX. Essentially, I now get to build the tools I wish I had when I was in those earlier QA roles.

You’ve worked across pharmaceutical, biotech, medical device, food & beverage, and manufacturing sectors over 18+ years. How has that experience shaped your perspective on what quality management systems need to deliver?

Working in all these industries, I’ve discovered they have more problems in common than not. Siloed data and spreadsheets, tribal knowledge, a lot of people saying “we’ve always done it this way,” and overall a lot of reactive firefighting. At the same time, I did have to structure my approach and process depending on the company, because each industry has its own nuances in terms of regulatory requirements, risk, and culture.

All of that taught me that when it comes to quality software, it has to have an opinion on best practices. But it should also be configurable enough to respect differences in how people manage their quality systems.

I also learned that a QMS can’t just be about checking a compliance box. It really needs to focus on the entire lifecycle—design control, risk management, change management, supplier quality, manufacturing, complaints, CAPA. You want to support that entire lifecycle but also have traceability that works when you’re being audited.

Working across industries also magnified the importance of integration. A quality system can’t exist in a vacuum. It has to be able to talk to different systems like LIMS, ERP, and regulatory systems.

Finally, I’ve learned that software adoption really depends on the experience of frontline users. If your operator doesn’t like the software, it doesn’t matter how compliant the workflow is. They’re going to work around it.

My experience has shaped my approach to QMS software by giving me an inside view on our customers’ challenges. I’m thinking about the inspector, the director of quality, the production line supervisor, the person on the floor entering the record at 2 a.m. I’ve seen all of those different pieces firsthand, and that gives me a unique perspective on what the software must do.

What excites you most about stepping into this role right now at AssurX?

Regulatory expectations are rising, customers want to modernize, and the technology is finally catching up to the vision many of us in quality have had for years for what an EQMS could be.

What excites me most is shifting from “delivering features” to driving outcomes at scale. In this role, I get to shape not only what we build, but how the full ecosystem of solutions works together to improve quality performance across industries. I’m excited to translate what we’re seeing across customers into a clearer product strategy—one that prioritizes the biggest areas of value and sets us up to win long-term. And I’m excited about continuing to embed analytics and AI into the product in ways that deliver even more value to our customers.

We’ve also built an engaged customer advisory board and user community. I’m looking forward to co-creating with them, which is something I never really had the chance to do working in industry roles.

On a personal level, this role brings together everything I’ve done previously and allows me to raise the bar on what people expect from a QMS software provider.

How does your experience working in industry inform your approach to product development?

Because I’ve done the work, I always have those real-world experiences in mind. I ask, what does a day in the life of a QA manager look like? What will an inspector ask for during an audit? How fast can someone defend this record and show traceability?

My quality experience in industry has really helped me stay focused on practicality. If a new feature adds five clicks but doesn’t reduce errors or risk, there’s still more work to be done.

I think about traceability, usability, and how different standards like ISO 9001, ISO 13485, and EU MDR translate into real work. My aim is to incorporate the intent of the regulations, not just the letter, in a way that feels natural to users.

How do you see quality management evolving in the next five to 10 years?

I definitely think we’re going to move from document-heavy quality systems into more real-time, data-driven, and predictive quality systems. Companies will be able to use signals from suppliers, from manufacturing, maybe even from the field to act sooner. I think the QMS will become even more tightly integrated with external systems like PLMs, ERPs, LIMS, and regulatory systems to manage the flow of data as it relates to change or risk or performance.

Expectations for the user experience are going to continue to rise. Even in highly regulated environments, people want systems that feel intuitive. Smartphones have really set the expectation that things should be intuitive and easy, and they should look good.

I think we’re going to see more industry-specific content out of the box, rather than asking every company to start from a blank slate. Of course, we already do that at AssurX, while also providing a high level of configurability, but I think we’re going to see more and more of that.

The last thing is the role of quality professionals. It’s going to shift towards design of systems and interpretation of data, and being more of a coach as AI and automation handles more routine tasks. I think we’ll be able to take a broader perspective rather than firefighting issues as they come up, helping coach the organization to solve issues with our guidance.

Can you talk a little about AssurX’s product roadmap in life sciences and manufacturing?

We just released enhancements to our CAPA solution, and next on the roadmap are enhancements to supplier quality. After that, I’ve developed a new solution for receiving and inspection management. After that, we’ll be working on enhancements to our risk management solution.

I structured the roadmap this way with the goal of deepening traceability within the product lifecycle. Design control, risk management, change management, nonconformances, CAPA, supplier quality—all of these solutions sharing data makes it easier to answer the question: what is the full impact of this issue?

Another goal within the roadmap is to expand shop floor and supply chain coverage. That’s where the receiving and inspection comes in, and improving supplier quality to better support monitoring and reevaluation. I’m also focused on improving collaboration features so that cross-functional teams like QA, operations, and R&D are all on the same page.

We’re also laying the groundwork for responsible AI enhancements. We’re starting with intelligent search across AssurX-provided resources, then expanding to allow for the incorporation of customer-specific content. Over time, we’ll extend AI into deeper product insights to help surface patterns and trends—each step designed to align with regulatory expectations.

What are the current AI capabilities in the AssurX platform?

Right now, we’re at version 1.0 of our AI tool, Izzy. She’s trained on our internal user guides, configuration guides, and troubleshooting content. Users can ask how-to questions, like how to create a new workflow, and Izzy pulls from these resources instantly. In future versions, users will be able to do even more with Izzy using their own documents and data.

From a big-picture view, our approach to integrating AI capabilities is measured and intentional. We want it to assist, not replace, quality professionals.

How do you see AI shaping quality management in the coming years?

AI is a powerful assistant for making sense of unstructured information. Doing things like summarizing complaints or deviations or audit reports, suggesting related records, helping users quickly find those cases.

I also think it’s going to help with triaging. Maybe it’s using historical patterns to suggest different risk levels or priorities, but still leaving that final decision with the quality professional, which is so important. You don’t want a tool making decisions on your behalf.

Over time, AI is going to help detect trends across suppliers and products that might be easy to miss when that data is scattered all over. It’s going to guide users through different investigations or assessments, maybe offering checklists and drafting problem statements, or bringing to light potential contributing factors to issues.

Through all of this, it’s so important, especially in regulated industries, that AI is governed, transparent, and auditable. I don’t see AI replacing human decision-making in quality, but I do see it taking friction out of the work. The organizations that are successful are the ones that pair AI with strong data governance, and a clear view of which decisions can be delegated and which can’t.

Tell us a little about your leadership philosophy.

I’m very much a proponent of servant leadership and see it as a service-based role. My job is to create clarity around roadmap priorities, remove obstacles, and ensure the teams I partner with have what they need to do their best work. I try to be both the voice of the customer and the advocate for our teams here, translating between what the market needs and what we can realistically deliver.

I care a lot about trust and accountability—making sure people understand the why, and customers know that we’re serious about our commitments. I also believe in being honest about risks and trade-offs, but doing it in a way that’s respectful and really looking towards improvement and not placing blame.

I love mentoring, and giving young professionals the tools and the knowledge that they need to be successful. In my role, I also try to be curious. I’m always listening, testing ideas, and learning from customers, peers, and the broader quality community.

Where do you draw inspiration from as a leader?

I draw a lot of inspiration from leaders I’ve worked with in the past who both held the bar high but were also deeply supportive and invested in my growth. I’m also inspired by customers doing amazing things with a lot of external constraints, and from peers in the quality community solving tough problems creatively.

Our current CEO is also a huge inspiration to me. Seeing how she’s built this company from the ground up while creating a culture of collaboration and innovation is truly amazing. If you asked me 10 years ago if I’d be a VP now, I would have said no. As a woman in leadership, she opens my eyes to what really is possible.

Discover more quality insights from Stephanie Ojeda in our free webinar, Human Factors in CAPA: Enhancing Engagement, Accountability and Management Commitment