Robbi Freisem

Senior Quality Assurance Consultant

Ms. Freisem is a subject matter expert in GXP Quality Assurance providing our clients with an effective CMC quality system management through drafting individual standard operating procedures. Her technical background is in drug substance manufacturing, small molecule and biologic API’s, sterile manufacturing, plant design, and technology transfer. She is a proficient negotiator of Quality Agreement and coordinating regulatory interactions with a CMO. Her capabilities include investigation remediation, lot release oversight, inspection preparation assistance, and site inspections providing extensive knowledge of ISO and cGMP requirements.

• Established and conducted GMP audit procedures
• Established quality systems and clinical quality assurance programs for start-up company
• Established supplier / vendor qualification program for GMP, GLP, and GCP contractors, CROs and CMOs

Ms. Freisem holds an undergraduate degree in biology serving in industry as a Quality department head with over 30 years at Wyeth, Centocor and Cardiokine.