GxP Insights: Dr. Sandra Smyth on Life Inside One of the Most Complex System Implementations in U.S. Pharma

With almost three decades of experience across regulated industries, Dr. Sandra Smyth has led several demanding technical programs within Life Sciences. In this edition of GxP Insights, Dr. Smyth talks us through one of them: a large-scale Manufacturing Execution System (MES) implementation at a global pharmaceutical manufacturer. i-Pharm GxP’s Hamish Corson sat down with her to unpack what a program like that looks like from the inside: the complexity, the stakes, and what it took to deliver successfully.

This is the first edition of GxP Insights' new format, a monthly interview series featuring senior professionals on some of the most complex programs in Life Sciences manufacturing. In keeping with i-Pharm GxP’s commitment to client confidentiality, the companies and sites featured in GxP Insights are not named.

For the first six or seven months of the program, Sandra worked without a single weekend off. Ten, sometimes twelve hours a day. Seven production lines running simultaneously across three shifts, operations and project tasks running in parallel, every day. The facility she worked in produces medicines that reach almost 60 million patients worldwide. The system she implemented couldn’t fail. And she did all of it remotely, without ever setting foot on site.

But that is not where it all started, so let’s back up a little bit first.

From Colombia to the forefront of Life Sciences Manufacturing technology

Digital Transformation and Automation specialist Dr. Sandra Smyth is a Doctor of Technology from Purdue University, where she also completed a post-graduate certificate in Applied Data Analytics. She is a Systems Engineer, holds an MSc in Business Administration from the Universidad del Valle in Colombia, and completed the Chief Technology Officer Executive Program at The Wharton School of Business at the University of Pennsylvania.

Her research sits at the intersection of AI governance, ethical AI implementation, and explainability requirements for high-risk AI solutions, a thread that runs through everything she does, and one she will come back to before the end of this conversation.

Her career started in 1998 in Colombia, as an engineering student working for a software development company building solutions for the utilities sector. Fast forward just five years, and Sandra was IT Director at one of Colombia’s largest hospitals, overseeing its information systems and everything connected to it. The move into pharmaceuticals came through that work: the hospital ran Oracle-based systems, and when she was hired to lead it, the skills transferred directly into healthcare and then into pharma.

More than twenty years on, she has led the planning, implementation, integration, and support of enterprise systems across some of the most complex regulated environments in the industry: from MES to ERP, CRM, LIMS, and more. The thread running through all of it has been the same: high stakes, highly regulated, and always at the intersection of technology and the people who depend on it.

Inside the program

Sandra worked as an MES Implementation Consultant and Enterprise Data Steward on a large-scale program running across circa thirty production lines at a global pharmaceutical manufacturer.

What does that mean in plain English?

A Manufacturing Execution System (MES) is the software that controls and records what happens on a pharmaceutical production line in real time: what was made, how it was made, by whom, with what materials, and whether every step met the required standard. A Master Batch Record (MBR) is the specific recipe and instruction set for producing one product on one line. Electronic Batch Records (EBRs) are the digital record of everything that happened during production, the evidence that every step was followed correctly. Sandra's role sat across all three: ensuring data integrity, system reliability, and compliant execution of those records. In a regulated industry, this is not administrative work. It is what regulators examine. One error can mean a batch cannot be released, and in a facility producing medicines for nearly 60 million patients worldwide, that is not a small problem.

“My role actually had two sides. One as part of the program team transitioning the legacy MES to the new platform, and one as part of day-to-day operations.”

On the project side, Sandra collected the parameter values needed for each line's MBR replication process, established the replication process for that specific line, and built in the quality tools to verify that every MBR was created with zero errors. She then verified MBRs for practice runs, qualification runs, and verification runs before coordinating the first commercial batch on the new system. After implementation, she remained part of the change management team, ensuring parameters were correct for new products and existing ones that needed updating.

This was also a flagship site. Whatever was built there, whatever was learned, would be replicated across other facilities. So Sandra was not just implementing a system; she was building the model that other sites would follow.

“With each line we learned something new, we became more efficient. It’s exciting to think that we would be able to bring all that experience to other sites.”

The consequences of getting it wrong were not abstract. The medicines produced at this facility reach patients across dozens of countries. Downtime is not just a performance or financial metric. It is a patient somewhere waiting for treatment that cannot be delayed.

“If we failed to release products on time, or with the quality required, there would be thousands, maybe millions of people affected around the world. We had people waiting for our product everywhere.”

Six months without a weekend off

The months without weekends off are not a detail Sandra raises to impress. She mentions them because that is what this kind of work has demanded at its most intensive phase. Seven production lines running concurrently, teams across three shifts, live operational demands running alongside implementation tasks. It was exhausting. She doesn't dress it up.

What is also true: as the program progressed, she trained the MES specialists on the new platform requirements for each line, and they progressively took their tasks back. The intensity was real, but temporary, and the work she did during it created the foundation that everyone else built on.

Presence without being present

Working fully remotely on a program like this is not a given. So how did Sandra pull it off?

“I had people asking me: how is it that you create that strong a presence within the team while working remotely? Good communication skills are the key.”

What she means by that is: making sure people feel free to ask questions. Providing clear directions and updates when asked for them. Being reachable. Being pleasant to talk to. Calling people by their names.

“You can argue that all this is basic stuff, but believe me, not everyone does it.”

The importance of being visibly fallible

Sandra adds something that does not often appear in professional advice about remote stakeholder management: the importance of being visibly fallible. Owning mistakes openly. Not performing a certainty you do not have.

“You have to show your team that you are also vulnerable, that you own your mistakes, that you are incorrect when you are. That creates a safe place. People love to work in that kind of environment.”

The same philosophy shapes how she approaches the early days of any new engagement. Twenty years of experience does not mean you know anything yet about the company you’ve just joined.

“You are new, you don’t know much about this environment. Respect that. Be like a sponge. Listen, ask questions, take notes. And very important: respect the history. Every decision that was made before you got there had reasoning behind it. Don’t be that person who cannot understand how they survived without you.”

The trust, she says, comes after. Once you have earned the right to be heard, your contributions land differently.

Building something that sticks

The moment that stands out most to Sandra from that MES program is not the hardest week; it is the MBR replication process she built from scratch. She defined it, documented it, and established it. Then watched it get adopted, not just on her lines, but across the whole program, to the point where she became the reference point that other teams would reach out to when they had questions.

“When you develop an application, you expect that to be used, right? It’s the same with creating a process. Putting that together from scratch and seeing it adopted through the whole program, to the point that makes you the point of reference: that is very gratifying.”

Sandra also went further than her original scope, but not because she was asked to. Early on, she noticed a gap: a process that needed defining and nobody clearly owning it. She had been collecting the relevant information anyway, asking questions nobody else was asking.

“I said: I have the information, I am capable of coordinating this. If you give me the resources, I can help out. And that’s how it happened.”

That is what consulting at this level can be like too.

Sharpening the pencil

Sandra has always moved between contracts and permanent roles throughout her career, and she is clear about what she sees as the real difference between the two.

“What I like about working as a consultant or contractor is all the intense learning you get during this type of program. It is like you are sharpening your pencil for the next assignment. You are getting stronger every time. That doesn’t happen the same way in a permanent position.”

In a permanent role, the focus is narrower by design. She’s not critical of that. It’s simply different. When Sandra returns to a permanent position after a contract, she arrives with more than she left with.

“I am a very dynamic person. There is always something new to learn and always a new challenge. With the contracts, that is when I get stronger.”

Her advice to anyone hoping to land a program of this scale?

“Be a sponge. Be passionate and let it show. Be reliable, not the person who needs to be chased. And from day one: do not sit still. Go and look for opportunities. Do not be shy. Send the message. Ask the question. Be present, even in a remote role. Go and make things happen.”

Outside the programs

Alongside her work as a Digital Transformation and Automation specialist, Sandra is starting a postgraduate program in Technology Law at the University of Edinburgh next fall.

Her academic interests sit at the intersection of emerging technologies, regulatory frameworks, and the evolving ethical landscape around them, and she sees a growing opportunity to help define how those technologies are governed within highly regulated industries.

“I believe that professionals who understand both the capabilities of new technologies and the legal structures, or gaps, that govern them are uniquely positioned to add strategic value to organizations. As a technical leader, I see this knowledge not as optional but as essential to remain relevant and effective in an era where automation and autonomous systems are rapidly reshaping everyday work and life.”

She closes on the same note she has been sounding throughout: stay relevant, stay curious, and mean it:

“Technology moves really fast, more than what we can actually handle. Try to be relevant. And enjoy it, because it is fun.”

About

Hamish Corson is an Associate Director at i-Pharm GxP, specializing in connecting senior professionals with SOW consulting engagements across major life sciences manufacturing programs in the United States. GxP Insights is our monthly interview series, giving you a look behind the scenes of the programs shaping the future of the industry. Subscribe so you don't miss the next one!

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