Expertise: Quality System design, optimization and compliance for pharmaceutical, biotechnology and combination products. Incremental Quality System development for start-up and new healthcare services e.g., preparation for phase 1/clinical use, specialty and homecare pharmaceuticals, compounding/outsourcing facilities. Planning for evolution from developmental > Preclinical/GLP > Clinical/GCP/GMP > Commercialization/GMP/Post Marketing Commitments. Remediation planning and compliance implementation for API, Finished Products and Data Integrity. Sterile product, Aseptic Manufacturing and Sterility Assuranc
Experience: Sterilization microbiology roots; Alternate Site Therapy Quality Assurance leadership (Home care pharmacy, compounding/outsourcing facilities); Established and led Baxter Hemoglobin Therapeutics Quality System and Organization. US and Global Quality Systems and Compliance leadership at TAP/Takeda Pharmaceuticals.
Other: Parenteral Drug Association (PDA), YWCA Woman of Achievement in Business Award, Planning Committee for the Great Lakes cGMP & Regulatory Science Forum, Northwestern University Biotech Masters Program Speaker