Virginia MacSuibhne is Solving the Compliance Puzzle

Roche Molecular Solutions’ chief compliance officer details her colorful approach to compliance

Virginia MacSuibhne, Roche Molecular

It’s laundry day, and you’ve just accidentally locked yourself out of the house while wearing only those embarrassing pajamas you would never want the neighbors to see. What do you do? If you’re Virginia MacSuibhne, chief compliance officer of Roche Molecular Solutions, you quickly concoct a clever solution by cobbling together elements of the unexpected.

“I had what I like to refer to as a MacGyver moment,” MacSuibhne says. “I’d locked myself out of the house but was still in my garage. I looked around and realized I had a garage full of options. So, I constructed a hook out of garden tools, a broom, and some duct tape. I pushed it through the cat door and dragged the leg of the table to where the keys were located—close enough so I could grab them and let myself back inside.”

As someone whose career has unfolded within the ever-updating healthcare arena, that example of ingenious creativity and problem-solving savvy comes in especially handy for MacSuibhne, who got her start as a litigator and now oversees compliance for Roche’s sequencing, molecular diagnostics, and tissue diagnostics offshoots known collectively as Roche Molecular Solutions.

“I’d describe my day as a juggling act,” she says. “I don’t ever know what’s going to come through the door. I plan for my day, but I also plan that 30 percent of my day will be ad hoc because, ultimately, I’m a service provider, and sometimes the business will have urgent needs. I have to switch between things quickly, because the reality is sometimes things just come up.”

MacSuibhne considers her overarching role to be someone who carefully sets the tone for compliance and assists the organization’s other leaders and managers in understanding as well as proliferating that tone, whether it relates to FDA regulations, cybersecurity concerns, or proper storage and acquisition of specimens.

“I’m really about strategy, leadership, and communication, because compliance is actually everyone’s role. It’s every employee’s responsibility,” MacSuibhne says. “My job is to enable that process and enable people to raise concerns, speak up, and to ensure that they have the guidance they need to move forward.”

That aspect, MacSuibhne explains, is clear-cut, given Roche’s strong set of organizational and cultural values that encourage employees to own their actions, innovate, and succeed as one.

“For me, those are great touchstones, and they make managing compliance in the organization so much more effective. They give velocity to it,” MacSuibhne says. “We work in a heavily regulated environment. What I never have to explain in our organization is why compliance is important. Everybody understands that compliance is our license to operate and that our reputation is important. People want to do the right thing when they go to work. My job and my team’s job is to help them understand what might be good choices in potentially gray areas so that they can be successful.”

To coax those successful outcomes, MacSuibhne focuses on putting people first and emphasizes being decisive, action-oriented, and generating inspiration. She also champions the importance of asking pointed questions.

“You have to be comfortable that you can’t know everything. I start conversations, and I spend a lot of time asking questions,” she says. “People will say that I’m going into cross-examination mode. What I’m doing is asking questions in order to feed the analysis.”

During the analytical process, MacSuibhne then sets her sights on scrutinizing the framework of a given industry regulation or compliance issue to discover why it exists in the first place, as well as to reveal what its core concepts are.

But problems and solutions aren’t always what they seem. “People often come to me and say, ‘I want to do X,’” MacSuibhne says. “They don’t necessarily want to do X. They actually want to do Y, but they think X is maybe the only way to get there. So, I try to start with the end goal—the Y—and not confuse that for its possible solutions.”

One of the major challenges of her role is navigating the often complex legal and ethical landscape of the healthcare industry. This leads into another aspect of MacSuibhne’s role: enable the business to do the right thing in the right way, while keeping in line with the company culture and within the boundaries of existing laws and regulations.

“On the other hand, technology is outpacing our regulations and laws exponentially,” she adds. “The job, and the challenge, is to figure out how to influence that and to navigate the gray space.”

Exploring the mysteries of that gray area has always captivated MacSuibhne. Agatha Christie and Nancy Drew books fascinated her as a child, and she is a voracious reader today. She also loves solving puzzles and adventure shows. In college, MacSuibhne designed her own major centered around social justice, which she describes as a combination of criminology and anthropology, and minored in women’s studies. “I’ve always had a sense of advocacy. There are no lawyers in my family, but in college I started interning at a law firm in San Jose,” MacSuibhne says. “No one was more surprised than me when I ended up graduating from law school.”

After working as a general litigator for Orrick, Herrington & Sutcliffe and an in-house counselor for financial software company Intuit, MacSuibhne joined Roche Molecular Systems as senior corporate counsel, eventually working her way to chief compliance officer of that organization and then to chief compliance officer of Roche Molecular Solutions.

She views her current position as an opportunity to offer the company creative solutions and options that will enable it to develop products that can best serve the diagnostics needs of not only the market and healthcare professionals, but also patients whose very lives are enhanced by Roche Molecular Solutions’ diagnostic tools.

“The patients are really the true north of working in diagnostics. I just can’t imagine a better place than healthcare,” MacSuibhne says. “I’ve worked at companies where they talk about providing life-changing products. Tech products are great, but healthcare is really life-changing. That’s what gets me up in the morning, and I feel very passionate having found the right place in
healthcare compliance.”

Photo: Sarah Sher

“Virginia leads by strategically and efficiently navigating the complex legal waters of compliance and cybersecurity in the healthcare industry. Her work, expertise, and initiatives set a high bar for other companies, as well as their legal counsel, to meet. Durie Tangri congratulates her on her recognition by Profile magazine, a well-deserved honor.” –Daralyn Durie, Partner

Shook, Hardy and Bacon is proud to partner with Virginia MacSuibhne and Roche Molecular Solutions. Successful business requires diligence to ensure the highest ethical and legal standards, and Virginia translates complex regulatory standards into a road map for extraordinary leadership. We look forward to a long and rewarding partnership with you!