Not many people light up when they talk about audits. But not everyone is Donna Callery.

A self-described puzzle-solver, Donna thrives on piecing together complex regulatory systems to ensure that Oligo Factory’s oligos don’t just meet the highest standards—they set them.

In her two years as Director of Quality Assurance, she’s helped lead the company through the kind of compliance landscape that can make even seasoned scientists sweat: ISO 13485 certification, ICH Q7 alignment, and the kind of robust quality management system that ensures safety for patients, customers, and employees alike.

Not bad for someone who once swore she’d never take another director role again.

Before Oligo Factory, Donna spent decades building quality programs in diagnostics, eventually joining a Fortune 500 med-tech giant where she worked across multiple product lines and traveled extensively as a supplier quality engineer. It came with great pay, unbeatable work-life balance, and the kind of security that’s hard to walk away from—especially as a mom with two kids in college.

“The interview at Oligo Factory changed everything. The lab was pristine, the leadership had vision, and the team were passionate, curious, and collaborative. There was a willingness to learn, to adapt, to grow,” she said. “It was a bit of a gamble, but I felt like it could really work out well.”

And it has. Beyond audits and SOPs, she’s had a chance to shape the company’s evolution—helping expand into therapeutics after years in research use products—and has been rewarded with meaningful moments, like seeing a GMP order she helped bring to life go toward helping treat a patient with a rare aggressive cancer.

“For me, quality is about more than documentation,” she says. “It’s about traceability, accountability, and ultimately, patient safety. And being able to play a part in making such a big impact is very exciting.”

Donna fell in love with STEM in high school—especially anatomy, physics, and calculus—and originally planned to become a doctor. But an early role developing infectious disease kits introduced her to the world of regulatory audits and quality systems. And she was hooked.

“When people ask, ‘What do you do?’ I tell them I put a puzzle together all the time, and I love it. I love the paperwork. I love the customer interactions. I love the auditor experience. I get to create a system and organize it. It really suits me, because I like objective, grounded things.”

As part of her role, Donna has helped build out systems for corrective actions, supplier and customer audits, training programs, and electronic documentation—all designed not just for compliance, but for long-term business success.

Her impact has extended beyond compliance. She’s helped guide a cultural shift—bringing structure, traceability, and accountability to a company that was scaling fast and pivoting from research to regulated manufacturing.

“It was a paradigm shift,” she recalls. “We went from ‘Why do we need all this documentation?’ to ‘Where’s the batch record?’ And now, people are proud of it. They’re proud when we get audited.”

Donna lives just 20 minutes from Oligo Factory’s new facility, but she’s still got a traveler’s soul. She runs, hikes, and participates in a wine-forward book club. She’s proudly raised three boys (two college grads and one future football star) and insists on at least four trips a year—including annual vacations to Aruba with her sister and big beach house reunions with her extended family in Rhode Island.

“It’s been an absolutely positive experience, and I’ve really enjoyed myself.”