Kareen O'Connell
Kareen O’Connell is a seasoned Pharmaceutical and Biopharmaceutical Quality Expert with over 30 years of experience in compliance, auditing, and systems development. Currently serving as a Quality Assurance Auditor at ADMA Biologics, Inc., she brings a deep understanding of regulatory frameworks, operational excellence, and quality system management. Her career spans compounding pharmacies, hospital pharmacy operations, and large-scale regulatory compliance functions, giving her a uniquely comprehensive perspective on quality assurance across the pharmaceutical lifecycle. With two decades of specialized work in 503A and 503B environments, Kareen has become a trusted leader in ensuring safe, compliant, and effective pharmaceutical practices.
Throughout her career, Kareen has demonstrated strong leadership in environmental controls, validation, CAPA management, documentation control, and regulatory readiness. As a Six Sigma Green Belt and experienced Quality Control Coordinator, she has led numerous process improvement initiatives that strengthened compliance, reduced non-conformances, and elevated product quality. Her expertise includes FDA, ISO, and ICH regulations—such as 21 CFR 211/820, ISO 9001:2015, ISO 13485:2016, and ICH Q10—as well as managing complex audits and regulatory inspections. She is also highly skilled in training teams on cGMP, SOPs, aseptic technique, equipment validation, and performance management, consistently fostering a culture of accountability and continuous development.
Earlier in her career, Kareen spent a decade in hospital compounding pharmacy operations, where she supported patient care through sterile compounding, automated dispensing technologies, OSHA compliance, emergency medication management, and interdisciplinary collaboration. Her ability to integrate technical expertise with strong communication and interpersonal skills has made her an effective mentor, builder, and advocate for operational excellence. Kareen’s leadership style is rooted in emotional intelligence, curiosity, attention to detail, and a commitment to helping organizations and teams thrive. With a proven track record of elevating quality systems and guiding high-performing teams, she continues to shape and strengthen the future of pharmaceutical quality and compliance.
• Florida International University - AS
What do you attribute your success to?
I attribute my success to my curiosity, commitment to learning, and confidence in my expertise. I never hesitate to ask questions, explore processes more deeply, and ensure that standard operating procedures are understood and followed with precision. These habits have shaped my approach to compliance and quality throughout my career.
As an Internal Regulatory Compliance Auditor at B. Braun Central Admixtures Pharmacy Services, I’ve developed a strong foundation in pharmaceutical and biopharmaceutical quality standards. My work has strengthened my ability to assess risk, navigate complex regulatory requirements, and support teams in maintaining excellence.
Looking ahead, I aspire to become a Director of Compliance, where I can continue driving a culture of integrity, continuous improvement, and regulatory readiness across the organization.
What values are most important to you in your work and personal life?
The values most important to me—both in my work and personal life—are integrity, accountability, and compassion. With more than 30 years of experience in compliance, auditing, and systems development, I’ve learned that strong values are the foundation of meaningful leadership. Mentorship is also central to who I am; I believe in supporting others, sharing knowledge, and helping future professionals grow with confidence.
I rely on emotional intelligence to navigate the workplace, build trust, and foster collaborative relationships. Whether I’m advocating for patients or guiding teams through complex regulatory requirements, I strive to lead with empathy, clarity, and respect.
Outside of work, I find balance through cooking, gardening, and traveling. I love exploring new cultures, spending time at the beach, and embracing experiences that broaden my perspective and bring joy to my life.