Highly skilled product development professional, who possesses vast experience working with cross-functional teams with a strong focus on Program Management, Process Engineering, and Quality Assurance within the FDA-regulated Life Science and Medical Device Industries. Build productive relationships between Sponsors, Vendors, CMO's, R&D, Quality, Engineering, Nonclinical, Regulatory and corporate teams to meet critical deadlines and performance targets and lay the foundation for lasting success.Twenty+ years of extensive skills and knowledge in:Project Management, Process Engineering & Improvement, Validation, CMO Management including PIP, Design Control, Manufacturing Expansion and Scale-up, NDA Authoring, PAI Preparation, GMP Documentation, Batch Record Technical Review, CAPA and Deviations.
Listed skills include Gmp, Pharmaceutical Industry, Fda, Medical Devices, and 45 others.