Staff Spotlight: Trish Schaefer

Please help us welcome Trish Schaefer, Senior Director, Quality Assurance, by learning a little more about her in this blog article!

Q: Passion and Purpose: What aspect of your work brings you the most joy and fulfillment?

What brings me the most joy in my work is helping teams avoid preventable problems before they happen. I enjoy looking at a process or study design and thinking through potential pitfalls, risks, and areas of vulnerability. For me, quality isn't about finding mistakes after the fact—it's about partnering with teams early to build systems and processes that support success. When quality is embedded from the start, it creates confidence, reduces unnecessary fire drills, and allows teams to focus on delivering great science while maintaining compliance.

Q: Collaboration and Teamwork: How do you foster a collaborative and productive environment within your team?

I believe people perform better when they feel valued, encouraged, and supported. In my experience, collaboration starts with treating people with respect and recognizing that everyone is trying to do good work.

Working in Quality Assurance can be challenging because there are times when firm boundaries must be maintained. However, I've found that explaining the "why" behind a requirement is often far more effective than simply enforcing it. When people understand the purpose and impact of a quality expectation, they are more likely to become engaged partners rather than reluctant participants.

I try to lead through education, transparency, and mutual respect rather than authority. I also believe a little humor and kindness can go a long way. Building trust, creating space for open dialogue, and helping people feel comfortable asking questions fosters a more collaborative environment and ultimately leads to better quality and better outcomes.

Q: Industry Insights: What trends or changes in your industry have caught your attention recently, and how is your work approach adapting?

One trend that has really captured my attention is the industry's shift toward Quality by Design and the expectations outlined in ICH E6(R3). For a long time, Quality Assurance was often viewed as the department that showed up after something went wrong. Today, there is growing recognition that quality is most effective when it is involved from the beginning, helping teams build strong, compliant processes before issues occur.

I see QA less as a referee throwing penalties and more as a guide helping the team navigate the course. We may still point out when something is heading off track, but our greatest value comes from helping teams understand risks, strengthen their processes, and make informed decisions before problems become costly or difficult to correct.

This shift has reinforced my focus on partnership, education, and proactive risk management. I enjoy working alongside teams to integrate regulatory expectations and industry best practices into their day-to-day work so that quality becomes part of how we operate, rather than something we scramble to address after the fact.

Q: Balancing Act: How do you manage to maintain a healthy work-life balance?

If I’m being honest, work-life balance is not something that comes naturally to me. I’m very much a “go all in” type of person. When I’m working on a project, I tend to become deeply focused and invested in it. Over time, I’ve learned that I also need periods to step away, recharge, and reset so I can come back with fresh perspective and energy.

My family helps keep me grounded. I have two teenage boys who have always provided a good reminder that there is life beyond work. While they don’t need me as much for the day-to-day things anymore, I treasure the concentrated time we spend together, whether that’s attending activities, sharing a meal, or just hanging out. My husband and family remain my top priority.

When I’m not working, you’ll often find me outdoors, spending time with friends and family, playing games, laughing, or reading. I consume books with the same intensity that I tackle projects. For me, balance isn’t about perfectly dividing my time—it’s about making sure I’m fully present for the people and experiences that matter most.

Q: Travel Wish: If you could travel to any place in the world, where would it be and why?

Normally, this question would be difficult to answer because there are so many places I’d love to see, but right now I’m about to embark on what truly feels like a trip of a lifetime.

In just a few days, I’ll be traveling to the Pyrenees Mountains after becoming fascinated by the stories of the courageous men and women who helped downed Allied pilots, injured soldiers, and others escape Nazi-occupied Europe during World War II. My interest was sparked by reading The Nightingale by Kristin Hannah, which led me to learn more about the real-life resistance networks that guided people across the mountains to safety in Spain and Portugal.

I’ll be participating in a local immersion experience led by a woman whose grandmother served as one of these resistance helpers. For a week, we’ll retrace portions of the routes used by these brave individuals, experiencing both the mountain crossings and coastal pathways that were part of their escape networks. I’m especially excited to walk the historic trails that carried so many people to freedom and to connect with a piece of history that has inspired me deeply. For me, travel is most meaningful when it combines adventure, culture, and a powerful human story—and this experience has all three.

Q: Mentorship Impact: How has mentorship played a role in your career?

Mentorship has played a significant role throughout my life and career. I genuinely enjoy learning from others and believe there is always something new to discover if we’re willing to listen, observe, and ask questions.

I’ve been fortunate to have several impactful mentors along the way. A pediatric dermatologist I first met in my youth who initially sparked my interest in science and inspired me to consider a career in medicine. Later, a vascular surgeon taught me the importance of adaptability and critical thinking—that sometimes the best solution isn’t found in a textbook, but through carefully assessing risk, using the resources available, and finding the path most likely to lead to a successful outcome.

Some of my most meaningful mentors, however, have been women who came before me. Through their actions, perseverance, and presence, they showed me that difficult challenges can be overcome. Watching them navigate obstacles, setbacks, and uncertainty gave me confidence that I could do the same. Their examples reminded me that strength doesn’t always come from having all the answers—it often comes from continuing to move forward when things are hard.

These experiences have shaped not only how I approach my work, but also how I hope to support and encourage others in their own professional journeys.

Q: Favorite Office Decor: Highlight a favorite item in your office that represents your personality or values.

Officially, I should probably say that my favorite office decor is the many photos of my two boys displayed throughout my office. Those photos truly are some of my most treasured possessions and serve as a constant reminder of what matters most.

Unofficially, however, my favorite “office decor” is much harder to hang on a wall. As my boys have gotten older and spend less time at home, my office has become the preferred gathering place for our family pets. Thanks to what I jokingly refer to as the “kitten distribution system,” we now have three rescue cats—Billie (sometimes called Wilson), Sunny, and Roxy, who earned the nickname “Squeaks” because that’s exactly what she does. They are joined by our incredibly loyal dog, Gracie, who probably missed her calling as an emotional support animal.

All four spend most workdays keeping me company, supervising meetings, and checking in to make sure I’m doing okay. They bring a lot of joy, laughter, and occasional chaos to my workday and serve as a reminder that some of life’s best moments are found in the simple companionship of those who share our space—whether they have two legs or four.