Provided direction for new product development in line with QBD and DTV principles on all medical device, drug and combination products.Clinical Production QA - Managed group of quality professionals responsible for the quality and release of clinical supplies. This group interacts with the R&D production facility on all clinical related production campaigns. Additional responsibilities include inventory management, risk assessment facilitation, QA release of all incoming raw materials and event management. Supplier Management - Conducted or supervised supplier audits for all R&D suppliers and contractors. Drafted and approved various Quality Agreements with suppliers and contract service providers. Led due diligence quality assessment at Japanese Aseptic Manufacturing facility.Lead for Combination Products MDD Independent Review (Apollo) - Lead the remediation efforts for PAI readiness of all Quality Systems (LIMS, Laboratory instruments, CMMS, Document Management, Change Management, NC,CAPA) that included review/revision of all validation documentation and regression qualification where needed. Event Management - R&D Quality Assurance approval for all Change Control, Non-Conformance, Environmental Monitoring Excursions, Root Cause Investigation, Document Management, and CAPA.Continuous Improvement - Lead enterprise wide product improvement around particulate matter that included process FMEA, specification revisions, regulatory review, design standards implementation, SPC monitoring program and new technologies feasibility assessments. Efforts resulted in zero observations in a June 2011 directed FDA inspection related to particulate matter.FDA lead for BIMO and PAI R&D QA - QA lead for recent FDA BIMO inspection (Lastacaft) and QA support for previous FDA/Notified Body/ISO/Foreign Regulatory inspections.Process Optimization/DEX - Replaced over a dozen discrete change control processes with one harmonized/efficient/complian

Process Optimization - Served as manager for ETQ quality systems application. Responsibilities included process harmonization for global regulatory affairs processes, technical and compliance interpretation of business partner requirements, and process optimization. Quality Systems Compliance Transition - Laboratory/Quality Systems PAI readiness role that has included GXP responsibilities for six medical device laboratories in preparation for FDA CDER inspection. This assignment has led to the evaluation and readiness plans for Change Management, Data Handling, Lab Records, Electronic Systems Compliance, Analytical Methods, Training Systems, Environmental Controls, Management Review, Materials Management, Calibration, and Contract Laboratories.

Transitioned from a support role to a compliance lead for quality systems. Provided leadership for Noramco as the Systems Validation Board Chairman. Managed projects and teams to strategic goals on local and global projects. Compliance/FDA - "Front Room" experience with FDA inspections from both CDER and CDRH during Pre-Approval Inspections, general cGMP inspections, and QSIT inspections. Direct FDA interaction during multiple inspections at both manufacturing sites; Developed strategic plan for FDA preparation prior to audits.Zero 483 observations in past 7 inspections (both sites).Process Improvement/DEX - Implemented a compliant electronic documentation solution that utilized my Design Excellence training and resulted in Design Excellence Green Belt Certification. Innovative methodology and process realized cost savings of $20k/year.Completed a global alignment of Change Management process and Document Management processes across WWCP and GPSG for the implementation of QUMAS.Delivered a global harmonized process for change control and document mgmt.Presented business case information for Capital Review.Quality Assurance - Served as backup for current QA manager on various QA roles. Taken lead roles in the following areas:Auditor in numerous QA internal, external, and customer audits.Delivered quarterly/annual management reviews.Served as QA Approver for Change Control, Quality Investigations, Non-Conformances, CAPA's, Validations, and other controlled documents.Participate in JNJ wide CAS, ANG, and Particle Size group as an officer.

Assisted in creation of SOPs and official lab practices.Performed and trained others in routine laboratory testing.