Bison Trailblazers |

by Anna De Cheke Qualls

When Dr. Eric Afoakwah begins to talk about his work, his tone is steady and unhurried—the voice of someone who has learned to think several moves ahead. From his home base in Washington, D.C., he reflects on the systems, people, and pressures that shape clinical research today. His style is part engineer, part mentor, part strategist, and entirely committed to one mission: building quality frameworks that protect patients while propelling new therapies toward approval.

An Origin Story Rooted in Howard—and the Continent

Before he was a senior leader in clinical quality assurance, Afoakwah was a doctoral student at Howard University, learning to thrive under pressure and to see excellence not as an accolade but as a baseline. He calls Howard his “launch pad,” a crucible where professors set a relentless bar and peers normalized brilliance. “A Howard education cultivates a solutions‑oriented mindset,” he says—one that prepared him to make mistakes, recover fast, and perform under scrutiny.

Mentors mattered. Icons of science and pedagogy—Drs. Winston A. Anderson, Lafayette Frederick, Clarence Lee, Franklin Ampy—pushed him to “dream big and shoot for the stars,” while researchers like Drs. Ayelle Gugssa and Norman Francis helped him develop a pragmatic and agile approach to research. Their combined influence endowed him with both the confidence and the method to compete for top roles in a space where African Americans remain underrepresented.

Two trips early in his doctoral journey reshaped his compass entirely. Funded by Professor Anderson’s MHIRT grant, Afoakwah traveled to the University of Bamako in Mali and to Korle Bu Teaching Hospital in Ghana. There, he studied tropical and infectious diseases—specifically, how herbal extracts might disrupt the attachment or progression of Plasmodium falciparum, the parasite responsible for malaria, as it invades red blood cells. Beyond the technical rigor, the work offered immersion in communities where the stakes of biomedical research are immediate, visible, and deeply human. The experience sharpened his instinct for translational research—the connective tissue between bench science and clinical reality.

A separate spark came from a 2011 essay by Professor Anderson in Science, “Competencies: A Cure for Pre‑Med Curriculum.” Although aimed at undergraduates, the piece became a turning point for Afoakwah. It gave intellectual permission to imagine a non‑traditional path. Mentor, article, and experience converged; together they nudged him toward the discipline where he would make his mark: clinical quality assurance.

"t was a defining moment for me as I considered my post-dissertation options, I realized that there were other professional opportunities that I could pursue outside of just experimental research at the bench. The article, as well as Professor Anderson’s selfless mentorship and guidance, gave me the confidence to consider and eventually pursue a non-traditional, industry-focused career," says Afoakwah.

Maryland Beginnings, Ghanaian Roots

Afoakwah’s story begins stateside. Born and raised in Maryland—the youngest of five and the first U.S.-born child in a Ghanaian family from the Asante region—he grew up in a home that was equal parts warmth and competition. 

"I consider myself incredibly fortunate to have had a brilliant, patient father and a resourceful mother. My siblings are smart, competitive, and have always offered encouragement and support, helping me stay productive and high-performing," observes Afoakwah.

A technology‑magnet program in high school opened doors to laboratories at the Applications and Research Laboratory and Johns Hopkins University. Still, it took a neighbor, Paul Thompson, who worked at Howard, to spark the college decision. Thompson chaperoned him to Homecoming; the campus energy did the rest. He was determined to attend. “Growing up in a household like ours was never dull,” Afoakwah says. “Those experiences taught me to adapt and be resourceful in any situation.”

Redefining Quality

Ask him to describe his work today and he’ll start with the non‑negotiables: “As a clinical QA leader, my core mandate is to ensure that subject safety is prioritized and appropriately monitored and that the integrity of trial data complies with FDA and other global regulatory requirements.” But he’s quick to add that Quality isn’t a brake pedal; it’s a steering wheel. “When implemented correctly, Quality Assurance adds value and positions organizations to better oversee drug development, shortening the pathway to approval.”

That philosophy is visible in how his approach has evolved. Early career instincts to “police” have been replaced by a posture of partnership—asking probing questions at the design table rather than pointing out gaps after the fact. He emphasizes three pillars:

• Partnership over policing: Integrate QA into daily workflows so teams see it as a problem‑solving ally.
• Risk‑based focus: Prioritize issues that affect centrally positioned or enterprise‑wide systems, not just isolated events.
• Continuous improvement: Fix systems, not just findings; build the capacity to learn.

In a sector where global trials are increasingly complex—multiple CROs, decentralized visits, real‑time data streams—his leadership style is as much about orchestration as it is about oversight. He aims to be “agile, thoughtful, fair, and transparent,” a steward who ranks risks so that outputs deliver net value rather than busywork. Governance, in his hands, is both structured and adaptive: the system bends so patients don’t break.

Demystifying the Inspection

Regulatory inspections loom like thunderstorms over clinical programs. Afoakwah sweeps away a common myth: agencies aren’t looking for perfection. “Inspections focus on whether systems exist to identify, escalate, and address issues and deviations,” he explains. The real question is reconstructability—can an inspector follow the breadcrumbs of decision‑making, see the logic of corrective and preventive actions (CAPAs), and verify that Good Clinical Practice (and related GxPs) were actually lived, not merely documented.

For preparedness, checklists alone won’t cut it. Afoakwah prefers to co‑author an inspection‑readiness framework with stakeholders, translate FDA and global health authority expectations into plain language, and rehearse the narratives teams will need in the room. He leans on the FDA’s Compliance Program and related guidance to simulate what regulators will scrutinize—and he has teams build storyboards and practice responses long before the badge shows up at the door. It’s not theater; it’s muscle memory.

Two Careers, One Compass

If his corporate remit delivers scale, his entrepreneurial venture offers latitude. Afoakwah founded Quality Assurance Partners & Consultants (QAPC) to test himself, expand impact, and create a pathway that didn’t depend on corporate politics or the industry’s often narrow notions of who gets to lead. “As a relatively young African‑American QA leader,” he says, having his own firm meant shaping a career where technical excellence could take the front seat—and where he could mentor young professionals who see themselves in his story. QAPC’s promise is succinct: listen intently, tailor solutions, and apply expertise across domestic and global regulatory frameworks so clients meet development, compliance, and approval goals.

Advising C‑suite leaders requires a different vantage. Executives need an enterprise dashboard: performance of the Quality Management System, trending risks, CAPA progress, and emerging headwinds that could derail timelines or viability. They need clarity, not granularity. Internal QA teams, by contrast, require detailed, actionable guidance. Afoakwah calibrates his communication to the room: “Strategic and concise” for leaders; “operational and technical” for the teams that will execute.

Balancing both worlds is demanding—he won’t pretend otherwise—but it’s energizing. 

"Honestly, it is demanding but immensely fulfilling. I’ve been fortunate to develop my technical expertise by working with some of the best biotech and pharma companies while also pursuing my entrepreneurial vision. Along the way I’ve learned to prioritize and manage actions, think strategically, collaborate, and communicate more effectively. I regularly seek candid feedback from colleagues and clients to understand what’s working and what isn’t; the industry forces you to self-assess and maintain high performance. Many friends and mentors juggle even heavier portfolios—board roles, business ventures, family obligations—but for me the value is evident in the business wins and continuous growth. The pressure of wearing many hats is both motivating and rewarding. Like Darwin’s theory of natural selection, adaptation is essential: in biotech and pharma you must adapt to survive and then thrive," observes Afoakwah.

Turning Foresight into Practice

Talk long enough with Afoakwah and the conversation turns to risk‑based quality, now a regulatory expectation and a practical necessity. In his framing, risk isn’t a specter but a signal—a variable to be measured, modeled, and mitigated. Clinical study teams and QA jointly “stress‑test ongoing plans and activities to ensure risks that could affect approval are identified, assessed, and appropriately mitigated.” The key is to move from episodic audits to continuous sensing, from reactive CAPAs to anticipatory design.

Here, artificial intelligence becomes more than a buzzword. He is already using AI, bots, and machine‑learning methodologies to accelerate oversight, spot trends, and surface recurring issues within QA frameworks. The frontier that most excites him is predictive modeling at the enterprise level—tools that can evaluate risk across systems, not just within a single protocol. For leaders under pressure to deliver, this is not academic. It is schedule, budget, and, ultimately, access to therapies for patients who cannot wait.

A Global Lens—With Africa in Focus

If his early research in Mali and Ghana launched a global sensibility, the future of QAPC aims to operationalize it. Afoakwah sees an inflection point on the continent: harmonization efforts between the European Medicines Agency and the African Medicines Agency, a rapidly maturing drug‑development infrastructure, and a population surpassing a billion—demographics and systems converging to reshape the market. He wants QAPC “best‑in‑class, growth‑enabling, data‑ and performance‑driven,” with the capacity to support clients wherever the work takes them—and with a particular readiness to serve emerging and historically underserved markets.

For all the talk of systems and strategy, the motive force is personal. Afoakwah grounds himself in “faith, family, and health,” the triad that keeps his pace sustainable in a high‑stakes environment. He prioritizes honest feedback—from colleagues, clients, friends, and family—and he cultivates joy with intention. These days, balance looks like a sideline view of his son’s soccer focus and a night out with his wife, small sanctuaries that replenish the energy he pours into work. “I try to keep life fun and lively,” he says.

What It Means to Lead in Quality—Now

Perhaps the best way to understand Afoakwah’s contribution is to listen for the shift in grammar. In his world, Quality is not a noun that sits on a shelf—nor a verb that scolds from the sidelines. It’s a design principle, embedded from protocol through submission. It is partnership, not policing; foresight, not fear; learning, not blame. It’s the difference between a trial that survives inspection and a program that is inspection‑ready by design.

He is candid about the demands. The biotech and pharma arena is a meritocracy in theory, a labyrinth in practice. Success favors those who can adapt—“Like Darwin’s theory of natural selection,” he jokes, “you must adapt to survive and then thrive.” He has adapted by building: careers, companies, frameworks, and, importantly, bridges—between regulators and researchers, systems and people, ambition and accountability.

The Road Ahead

Look forward a decade and you can see the contours of Afoakwah’s ambition: QAPC as a global leader in regulatory excellence, powered by data and performance, with a footprint that spans established centers and ascendant markets alike. In his vision, predictive AI augments human judgment; risk is mapped in real time; inspections validate what teams already know because the system has been telling them—clearly, continuously, and early. Patients win because therapies arrive sooner and safer. Sponsors win because certainty replaces guesswork. And quality professionals win because their craft is recognized as the strategic engine it has always been.

Back on the interview, Afoakwah's topic shifts to gratitude: mentors who opened doors; a university that demanded excellence; a family that keeps him honest and whole. The narrative is tidy only in hindsight. In the moment, it was a series of choices—some inspired by an article, some by a flight to Bamako, some by a conviction that systems, when designed with care, can move mountains. Dr. Eric Afoakwah’s story is not merely about climbing the ladder. It’s about building the scaffolding so others can climb—safely, swiftly, and with purpose.