Meg Gallwitz JAG Healthcare Consulting, LLC

Meg Gallwitz

Meg Gallwitz JAG Healthcare Consulting, LLC

Meg Gallwitz is a quality and compliance leader with over 30 years’ experience. Meg began her career in parenteral products with roles in QC, Quality, and Audits and Compliance. As an industry consultant, she has developed specialized expertise in Data Governance and data integrity.

Meg excels in the development and implementation of quality systems that meet compliance requirements yet are achievable and sustainable for her client’s organizations. She has developed and executed a global quality plan for a multi-site global supplier of excipients and API’s and assisted a foreign manufacturer with the development of a QMS to support the manufacture of a cannabis product for clinical study. She has managed and executed the external audit program for a virtual pharmaceutical company headquartered in the US, a role that involved interacting with senior leadership to assess and resolve high-risk compliance issues. Most recently Meg has assisted both US and foreign manufacturers in the execution of internal data integrity and manufacturing investigations as well as developed and delivered site wide training on cGMPs and Data Integrity.

Meg holds a bachelor’s degree in Chemistry from Rutgers University and is an ASQ Certified Quality Auditor and Certified Pharmaceutical GMP Professional.