Lori Morway

About Lori Morway

Quality Executive with extensive experience in sterile drug and biological products manufacture including aseptic processing, blow-fill-seal, and Lean manufacturing. Proven success in leading high performing Quality teams in an outsourced manufacturing business model for multiple dosage forms (solid oral, sterile, combination products, thin films) including providing quality oversight for 30+ contract manufacturing organizations. Highly engaged authentic leader with proven ability to collaborate effectively at all levels of an organization to influence and create shared purpose. Effective decision maker with ability to successfully balance achievement of business objectives and GXP compliance.•Demonstrated ability to implement and sustain robust Quality Systems including design and establishment of 21 CFR Part 4 Combination Product and Good Distribution Practice frameworks.•Established history of successful interaction and trusted working relationships with Regulators.•Critical thinker with ability to understand complex technical issues; ability to interpret, investigate, and resolve process/product deviations and to identify effective CAPA.•Proven ability to lead through significant periods of change while maintaining highest quality standards (organizational transformation to Lean manufacturing model; transition from regional to global supplier; site closure/reductions in force).•Excellent communication skills, positive assertiveness, and continuous improvement mindset.

Experience

1. Founding Member

   Camp Chateau

   Feb 2025 — Present

Education

• Oakland University

  BS, Biology

Skills

• Deviations
• Cleaning Validation
• Quality Control
• Gmp
• Gcp
• Pharmaceutical Industry
• Sop
• Fda
• Capa
• Validation
• Trackwise
• 21 Cfr Part 11
• Quality System
• V&V
• Regulatory Requirements
• Gxp
• Quality Auditing
• Aseptic Processing
• Pharmaceutics
• Quality Assurance
• Change Control