Haleigh Wetzel

Haleigh Wetzel joined BTL in 2022 as quality assurance consultant, specializing in quality system implementation, regulatory documentation, and GxP compliance across the biotech and pharmaceutical landscape. Her expertise spans a diverse range of products, including vaccines, gene therapies, peptides, and medical devices. Haleigh’s career has focused on supporting quality system readiness and regulatory compliance, ensuring her clients are fully equipped to meet international FDA standards and maintain operational excellence.

Haleigh’s career began in clinical research, where she developed a strong foundation in GCP as a Clinical Research Coordinator at Finger Lakes Clinical Research, coordinating subject recruitment and data management. She then moved into protocol management at institutions like the TIMI Study Group and ECOG-ACRIN, where she supported clinical operations and maintained quality control standards. At Astellas Pharmaceuticals, Haleigh advanced her skills in quality improvement initiatives, serving as a pivotal point of contact for process mapping and project strategy.

Since joining BioTechLogic, Haleigh has taken on extensive quality management responsibilities, including supporting international FDA remediation projects and overseeing quality systems implementation for high-impact clients. Her work with electronic document management systems and her leadership in developing training programs have proven instrumental in helping clients meet GxP requirements with confidence. She also manages vendor audits, regulatory documentation, and document control processes, providing end-to-end quality assurance support.

With BioTechLogic, Haleigh has found an ideal platform to leverage her regulatory expertise while gaining insights across various product development stages. Some of Haleigh's strengths include her analytical approach, her ability to identify and strengthen key compliance areas, and her strategic guidance on complex quality management projects.