Design, deployment and management of Product Lifecycle Management systems to improve quality and business efficiency.

Remediation activities relating to Risk Management and Design Control within the R&D Quality Assurance function.

Provided quality leadership and oversight for R&D project teams developing new contact lens products for the astigmatism platform. Assured customer requirement traceability through the risk, design and CTQ process. Assured design control elements were delivered per the development plan including verification and validation activities. Implemented new systems (DC, Risk, & Knowledge Management) for R&D projects as part of compliance remediation plans. Approved project plans, design reviews, and project gate reviews, as well as Design History File audits.Approved test method validations and methods.

Managed the stability programs for device and combination products within the Acuvue brand to assign expirations dates and storage requirements. Worked extensively on the combination product Acuvue Theravision lens with the antihistamine Ketotifen, the first drug-eluting contact lens authorized for marketing in the U.S. Designed and implemented new stability practices for pharmaceutical and lens care products. Responsible for all investigations, CAPAs and deviations relating to stability non-conformances. Regulatory affairs author for storage and expiration dating sections (510(k) & PMA's).

Implemented new systems for Design Controls for Combination Products. Provided pharmaceutical input into the design of new combination product development systems. Influenced and trained the R&D Organization to deliver products meeting both Device and Drug regulations. Leveraged change in many areas of a device business expanding into pharmaceuticals including stability, specification development and quality assurance.

Managed the Technical Services function for a large Contract Manufacturer of finished pharmaceuticals. This group provided Project Management services as well Quality System support to ensure the smooth introduction of new products into the site. Primary activities of this position involved the Supervision a staff of ten scientists that performed production support functions such as Manufacturing Investigations, Statistical Analysis, Corrective Actions, Batch Record Revisions, Development Trials, and Process Improvements.

Managed Quality Assurance aspects for the contract manufacture of a sterile biotech lyophilized product. Negotiated Contract and Quality Agreement aspects for manufacture and testing. Coordinated site changes necessary for regulatory compliance and control. Key liaison with Eli Lilly and their man-in-the-plant staff of six professionals supporting the manufacturing of the product Xigris.

Managed the start-up of Analytical Laboratories, Quality Control and Quality Assurance functions for a new sterile Ophthalmic Division of CIBA Vision. Implemented Quality Systems for this International Division that included extensive interaction with contract facilities and component suppliers. Managed the evolution of this Quality Unit into the Novartis family of companies. Matured the group to include Regulatory Compliance, Training Programs, Change Control, Electronic Document Control and Process Validation (staff of 5 - 10). Key player in the approval of several NDA's and Supplements. Developed and launched new products that incuded Genteal, Aquasite, Voltaren Ophthalmic, Visudyne, Vitravene, and Zaditen. Provided marketed product support to the series of IOLAB products purchased

Organized and performed company wide audits (ASQ Certified) per device GMP's and ISO Quality standards in the "CE" certification process for various sites.

Managed quality and regulatory related activities for a startup pharmaceutical firm developing drug device combination products. This included managing the analytical laboratory, methods development, control of injection molded plastics, GMP compliance, and the submission of DMFs, INDs and NDAs. Contributed in the development of various microgranular drug delivery products utilizing scanning electron microscopy and other analytical techniques to study coating efficiency.

Site Regulatory Liaison for inspections. Performed internal and external GMP audits. Interaction with contract manufacturers, vendor control, product complaints, process validation, documentation maintenance, NDA Compliance, and product recalls.

Supervised a Stability and Quality Control Laboratory testing in-process and finished pharmaceuticals. Broad experience with pharmaceutical analysis including dissolution, chromatography, methods development, and troubleshooting. Worked with various products and materials including transdermals, dermatologicals, controlled release solid dosage forms, and raw materials. Supported products such as Theodur, Nitrodur, Nicospan, and many others that were eventually sold to Schering Plough.

Developed and operated a new aseptic production line for the manufactured of fruit juices allowing shipment and storage of products at non refrigerated conditions.