How Her Career Journey Unfolded
Her career journey unfolded at the intersection of engineering, quality, and execution. Stephanie began as a junior electrical engineer at CRB. She then moved into pharmaceutical quality and validation at Pfizer. Those early years gave her a strong appreciation for disciplined fundamentals: clear requirements, traceable decisions, and solutions that work in the real world—not just on paper.
From there, she expanded into larger programs and enterprise leadership. At Baxter/Baxalta/Shire, she led CSV strategy and execution during major capital expansion work, guiding teams through life cycle deliverables while maintaining strong controls for data integrity, traceability, and inspection readiness. She later advanced into global validation leadership at Takeda Plasma Operations (Shire), strengthening governance and consistency across a broad site network and reinforcing practical, risk-based ways of working.
Beginning in 2019, Stephanie broadened her impact to enterprise capital delivery practices at Amgen—authoring end-to-end project playbooks that embedded CQV and operational readiness gates and building communities of practice to align standards and execution across teams. Most recently, as global validation director at Emergent BioSolutions, she guided global governance for validation and operational readiness while supporting digital modernization efforts to improve cycle time, transparency, and consistency across the organization. Today at A-Bio, she continues to bring that same blend of strategic perspective and execution focus to teams navigating tight timelines, complex systems, and high expectations.
What She Enjoys Most About Her Work
What Stephanie enjoys most about her work is the people. Across companies, sites, and disciplines, she has collaborated with exceptional professionals who have taught her a tremendous amount about the pharmaceutical industry—from technical problem-solving to leading under pressure. She values the shared sense of purpose that comes with delivering safe, reliable medicines for patients.
A Project She Is Proud Of
One project she is especially proud of captures the way she likes to lead: standardizing a global CQV program while simultaneously bringing on a digital validation platform. The objective wasn’t standardization for its own sake—or “digital” as a buzzword. She designed a cohesive global approach that teams could execute consistently, then aligned the digital tool to the process so it reinforced good practice rather than adding friction. The outcome was a seamless global program paired with a digital validation solution that supported it end-to-end—creating smoother execution, clearer visibility, and easier adoption across sites.
Stephanie’s industry impact is closely tied to her long-standing involvement with ISPE.
What She Enjoys Most About Being a Member of ISPE
Stephanie’s industry impact is closely tied to her long-standing involvement with ISPE. She has contributed through guidance and knowledge-sharing efforts, including supporting Good Engineering Practices and co-leading the Digital Validation Guidance Document team, along with ISPE webinars and published articles. She has served in leadership roles within the ISPE C&Q community for several years, and in 2026 she serves as Chair of the ISPE C&Q Community of Practice Steering Committe. What she enjoys most about being a member of ISPE is the people. This includes the mentors, coaches, and collaborators who have helped her grow, challenged her thinking, and become part of a trusted professional network. She values having a community she can call anytime to ask a question, compare approaches, or pressure-test an idea. She credits ISPE membership and engagement with opening doors to collaborations she would never have found otherwise.
Stephanie holds master’s degrees in engineering management and biomedical quality systems, and bachelor’s degrees in electrical engineering and education. Outside of work, she enjoys watching the New England Patriots with her husband, hanging out with her older son and grandson, and watching her younger son play college baseball. Her favorite words to live by are simple and direct: “If not now, when?”
