B.S in Engineering with over 25 years of professional experience.
• M.B.A in Operations Management with over 20 years of Management/Leadership experience.
• ASQ and RABQSA (ISO 13485) Certified Quality Auditor with over 5+ years of auditing experience.
• 18+ years Computer System Validation experience.
• 10+ years of Project management experience with in Pharmaceutical Industry.
• Strong understanding of Quality Systems like CAPA, SPC, LEAN and Six Sigma.
• Strong knowledge of GXP, 21 CFR Part 11 regulations, GAMP 5 and Computer System Validation.
• 10+ years of hands on PLC, SCADA, DCS, Building Automation Systems programming experience.
• 10+ years of experience in QO Laboratory Information Management systems such as LIMS, MIMS, EMSS, and Agilent CDA system for HPLC and GC systems.
• 18+ years of on-site Manufacturing plant experience, familiar with plant safety, OSHA regulations.
• 15+ years of hands-on Manufacturing Process Improvement experience.
Solutions-focused Validation leader with a solid track record leading complex Validation and Regulatory Compliance projects, building and rebuilding high performance teams, and executing company-wide strategies. Able to instill “big picture” perspective throughout organization and drive long-term outcomes within technical groups. Skilled in aligning technology with business goals, pinpointing areas to achieve improved performance and successful turnaround efforts.