25 years Engineering & Regulatory experience in Pharmaceutical & Medical Device industries focusing on Unique Technologies, Product Design & Development, Manufacturing, CMO collaboration and Quality Engineering. 16 years spent on end-to-end lifecycle management and development of medical device and medicinal combination products; user requirements, design inputs, design verification and validation, comparative effectiveness studies, risk management, product reliability, statistical analytics, quality and manufacturing engineering initiatives and continuous improvement. Management • Quality Engineering Manager with direct reports. • Leader of Continuous Improvement Projects/ Technical teams.• Employee Mentorship. Technical• Development of and Harmonization Standards and Quality Systems.• Development of strategy to implement change and ensure Continuous Improvement.• Proof of concept realization of medicinal products.• Application of 21 CFR-820: Quality System Regulation, 21 CFR 210 and 211, ISO 14971 & ICH-Q9: Quality Risk Management, ICH-Q10: Pharmaceutical Quality Systems, ISO 13484: Quality Management System.• Development of Pre-Filled Syringes, Implants & Electro-Mechanical Injection Devices• Global Contract manufacturing Organizations (CMO) Collaborations • TechnologyTransfer from concept to clinical & Commercial Manufacturing.• Quality Assurance, Quality Engineering and Risk Management.•Application of Six Sigma initiatives.PROFESSIONAL HIGHLIGHTS• External Focus: Grasp the big picture. • Future Changes: Challenge the status quo, and establishes goals and requirements for competitive advantage.• People and Results: Achieve results with people by enabling and energizing others.• Quality and Speed: Make decisions and execute work plans to achieve results.• Evaluate and Act: Evaluate results and adjust course as needed.• Value: Relentlessly pursue excellence, create partnerships and provide leadership with integrity through daily conduct.
Listed skills include Six Sigma, Design Of Experiments, Validation, Design Control, and 24 others.