Mary Swartz

With more than 20 years of experience in pharmaceutical quality operations, Mary brings deep expertise across cell therapy, biologics, small molecules, gene therapies, and viral vectors. Over the course of their career, she has successfully led greenfield and brownfield laboratory builds, managed complex global product launches, and driven quality excellence across multiple organizations. Her work has spanned the U.S., Europe, and Asia, with extensive collaboration alongside regulatory agencies such as the FDA, EMA, Health Canada, and PMDA.

Previously serving as Senior Director of Quality at Vor Bio, Mary provided strategic quality leadership across product programs, CMC functions, and laboratory operations. She championed a culture of compliance and patient-centricity, and serve as the company’s primary Quality representative in health authority interactions. Mary's leadership ensures that product development and operations consistently align with regulatory expectations while supporting innovation and efficiency.

Prior to this role, Mary held leadership positions at Resilience and Takeda, where they directed global quality control programs, guided laboratory operations, and managed cross-functional teams through regulatory inspections, product launches, and analytical method lifecycles. Earlier in her career, she advanced through roles at Shire, Bristol Myers Squibb, and SRC, Inc., where they contributed to particle lifecycle management, molecular biology assay development, and novel nucleic acid technology—earning several U.S. patents in the process.

In addition to technical and regulatory expertise, Mary is a dedicated mentor and leader, known for building high-performing teams and fostering professional development. They have overseen international teams, guided large-scale system implementations, and developed quality strategies that scale with organizational growth. Her ability to balance scientific rigor with business priorities has made her a trusted partner to both executive leadership and external collaborators.

Beyond her professional achievements, Mary is deeply engaged in the community. They volunteer with the Stow Food Pantry, coach youth soccer and basketball, is a Board trustee at a local charter school focused on STEAM education, and serve as a professional mentor.  She brings not only technical excellence but also a strong sense of inclusivity and service to every role she takes on.

Vor Bio
Senior Director, Quality

Resilience
Head of QC Product Testing and Laboratory Logistics

Takeda
Associate Director - Large Molecule QC Lead

Shire
QC Technical Programs and Cell Banking Lead
Senior Scientist II

SRCTec, LLC
Lead Technical Research Scientist

Bristol Myers Squibb
Assistant Scientist II

Adecco Staffing
Validation Technician

Stiefel, a GSK company
Quality Control Analyst

• 2002 BSc. Biochemistry, Union College (Schenectady, NY)
• 2007 Graduate Certificate in BioProcess Engineering, Syracuse University (Syracuse NY)