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Before serving as a quality tech executive, Wendy Zambrana says her passion for supporting patient-centered organizations started early.
“I’ve always wanted the ability to be part of a greater narrative and have a meaningful impact. I grew up in New Jersey, where there’s a heavy presence of pharmaceutical companies like [Johnson & Johnson], Merck, and Roche,” Zambrana says. “So, it was natural to see myself in that environment. I wanted to contribute to delivering therapies to patients and it goes back to being part of that story and having a positive impact on people’s lives.”
At the beginning of her twenty-five-year career, she got a chance to make her mark in healthcare as a validation engineer at pharmaceutical companies and consulting firms. The role gave her an appreciation for manufacturing processes and taught her to think on her feet. Meanwhile, her consulting experiences exposed her to another passion: change.
“I love ambiguity and I love building new capabilities,” she says. “I see it as an opportunity to put something innovative together. And in consulting, you’re assigned to many projects and each one has its own timeline. Every project is like starting at a new company. You’re trying to understand the dynamics of the culture, the key stakeholders, you have multiple managers and you’re trying to keep everyone happy. I credit the work style I have today to that environment.
After improving processes, integrating systems, and participating in multiple manufacturing facility buildouts, Zambrana was ready for a change and Biogen was just the place. Founded in 1978, the company is a pioneer in biotechnology and has a leading portfolio of medicines to treat multiple sclerosis, introduced the first approved treatment for spinal muscular atrophy and is at the forefront of neurology research. Zambrana was drawn in.
“Biogen was very well-known for having a great patient-centric culture,” she says. “And by then I had worked for multiple large pharmaceutical companies, with well-established programs and processes. I wanted to drive and influence change and saw that Biogen was a place where I’d have more possibilities for growth and make a difference.”
Since joining the company in 2007, Zambrana has had an opportunity to evolve and take on various positions underpinning her ability to build teams and drive transformation.
In her first role, she provided guidance for quality systems, implemented a redesigned quality management system, and developed a digital solution integrating US and international packaging and artwork frameworks. From there she transitioned to the quality engineering function, managing all validation and operational activities within a clinical and commercial manufacturing facility and established the quality governance model for IT enterprise systems. Today, she’s head of IT quality and oversees quality operations for digital technology systems and regulatory compliance efforts at a global scale.
While she led the harmonization of a computerized systems program, bolstered compliance, and enabled faster implementation of technology, she’s most proud to be guided by servant leadership principles.
“I’m people centric. Without our people we can’t achieve excellence. My job is to empower and enable my team to be successful while setting the strategy for them to deliver on,” Zambrana says. “I also operate with transparency and am not afraid to go in the trenches with them. If I’m not able to do so, how can I ask it of others?”
Outside of work, Zambrana has focused on joining organizations that support women. She currently serves as cochair of the MAPS committee for the Boston chapter of Women in Bio (WIB), an organization designed to support women in different professional and personal development stages. What started as a way to network during the pandemic quickly turned into a way that she could give back to young professionals.
“Women in STEM are underrepresented and need to be encouraged to explore the field. Part of my contribution has been to just pay it forward and help women understand the opportunities that exist in my industry,” she says. “Being part of a mentoring committee connecting mentees with other professionals who can have those conversations has been important.”
Young people wanting to succeed in their careers should take chances and explore different opportunities, even if it means going beyond what they went to college for, Zambrana says.
“It’s okay if your interests change over time. Keep learning and be open to pivoting,” she says. “Too often we get locked into what we studied but you can do something else. Be confident, willing to reach out, and ask questions. It’s important to find the right mentors, and support networks.”
At Osprey Life Sciences we focus on supporting our client’s success by helping ensure that the software solutions they use are properly deployed, managed and compliant. We have a talented team of experts in areas such as project management, compliance, regulatory, software implementation. and integration specifically for the life sciences industry. Our flexible services model accommodates clients’ needs by providing products, managed services, project-based delivery, and client-managed staffing. We work with clients of all sizes and phases of evolution from the global pharmaceutical companies to fledgling biotechs in both regulated and unregulated environments. Please visit our website at ospreylifesciences.com.