Executive leader with over 25 years of expertise in all facets of biotechnology, pharmaceutical, medical device industry in QC, QA and Quality Validation Engineering. Accomplished in collaborating with a team to drive quality improvement initiatives. Instrumental in streamlining and improving processes, enhancing productivity, and implementing compliance solutions.I can apply a unique combination of skills to achieve positive outcomes when managing the challenges within the health science industry. Career highlights include: Developed policies and procedures for QMS that harmonized customer and regulatory compliance for 40+ manufacturing sites, and 200+ Contract Manufacturing Organizations and Contract Service Organizations. Served as expert for interpreting governmental regulations and implementing compliance procedures to 21 CFR parts 210, 211, 11, PIC/S, Annex 11, ISO 13485, ISO 14971, Guidance for Industry for Sterile Drug Products and Good Clinical Practices. Created risk base GxP Programs to streamline customer and regulatory efforts without compromising compliance integrity and monitored conformance with cGMP’s.