At Abzena, our commitment to excellence in quality engineering is driven by the passion and expertise of our people. In this spotlight, we share Tina Steffan’s journey as our Senior Director of Quality Engineering at our San Diego biologics manufacturing facility.
Tina’s diverse background in chemistry, computer science, and business has shaped her approach to ensuring our systems remain robust, compliant, and reliable. Her experience and thoughtful commitment to quality have supported our efforts to improve and adapt to a continuously changing environment.
Setting The Foundation
Tina’s journey began with a solid foundation in science that has evolved into a multifaceted career combining chemistry, technology, and strategic business insight. After earning her BS in Chemistry from the University of Pittsburgh, she started her career as an organic chemist at a small pharmaceutical company in Baltimore. It wasn’t long before her curiosity led her to explore molecular modeling and supercomputing, transitioning into programming systems to manage chemical inventories and biological testing.
Recognizing the power of merging science with technology, Tina pursued a second BS in Computer Science while continuing to gain hands-on experience in the field. This blend of expertise allowed her to work on innovative systems—ranging from genomics sequencing platforms to laboratory information management systems—across various biotech and pharma companies. Later, after moving to California, she furthered her professional growth with an MBA from SDSU, deepening her understanding of business operations and strategic planning.
Tina’s professional journey reflects her steady commitment to learning and adapting, skills that have been instrumental in her transition into leadership roles. Her career path is a testament to her balanced approach, where technical prowess meets thoughtful leadership in quality engineering.
Essential Expertise for Success
Tina plays a pivotal role at Abzena, ensuring that our regulated systems meet the high standards required by GxP compliance. In her capacity as Senior Director of Quality Engineering, she oversees computer validation programs, safeguards electronic data integrity, and ensures adherence to 21 CFR Part 11 requirements across our global operations.
Each day, Tina collaborates closely with teams across multiple sites and engages with senior leaders to align new technology initiatives with business priorities. Her responsibilities include managing the balance between stringent regulatory requirements and the dynamic pace of business, all while guiding risk assessments and continuous improvement efforts.
By providing clear oversight and strategic direction, Tina ensures that our systems not only meet compliance standards but also contribute to Abzena’s broader mission of supporting impactful outcomes for our clients and the patients they serve.
According to Tina, success in quality engineering hinges on a deep blend of technical and regulatory expertise. A robust background in IT and compliance, built over decades of hands-on leadership, is fundamental. While academic credentials are valuable, Tina believes that practical experience in development and managing compliance challenges is what truly counts. She expresses – “What I enjoy most about my role is seeing how the work we do in quality engineering directly impacts both the business and the patients our clients serve. It’s rewarding to know that by keeping our systems compliant and reliable, we’re helping advance therapies that make a real difference.”
She underscores the importance of transparency and diligent engagement with every aspect of the business. In her role, clear communication and a hands-on approach ensure that quality is never compromised—even as production pressures mount. This balance between technical acumen, regulatory rigor, and collaborative leadership is at the heart of the role, setting a high standard for quality engineering at Abzena.
Work Environment & Cultural Insights
Tina appreciates Abzena’s balanced approach to work, where collaboration and connectivity are at the forefront. As a global quality engineering leader, she regularly engages with teams across various sites—ranging from Bristol to Cambridge. At the San Diego site, the spacious communal areas encourage spontaneous discussions and in-person exchanges that enrich the daily workflow. Although the environment can be lively, it remains energizing and well-suited for effective teamwork.
In addition to its dynamic workspaces, the San Diego location offers local amenities that enhance the overall experience. With a welcoming neighborhood and a nearby cafeteria, employees enjoy a sense of community. And, of course, the consistently pleasant weather—sunny days with an average of 72 degrees—adds to the appeal, making it a practical and enjoyable place to work.
An Incredible Impact
Tina’s story at Abzena is a reflection of dedication and thoughtful leadership. Her blend of technical expertise and a steady commitment to quality drives not only robust regulatory practices but also a supportive and collaborative work environment. By balancing complex challenges with genuine care for the people behind the systems, Tina continues to make a meaningful impact on our team and the customers we ultimately serve. Her journey is a reminder that consistent passion and practical experience are at the heart of every success at Abzena.
Interested in learning more about our open career opportunities? Visit: Careers at Abzena
