Responsible for Global Operations at Exemplar Compliance supporting company growth and expansion of professional services.Key Responsibilities:-Identifying and recruiting senior consultants (20+ years)-Building Teams to support Client needs and fit with Client culture-Business Development and Partnerships-QMS Creation and Improvement-Product Design Planning & Validation-Computer System Validation, C&Q

Boehringer-Ingelheim C&Q Lead at retrofit manufacturing facility.-Led team in the development and execution of test protocols-Facilitation of Risk Assessments-Development of C&Q Plans

C&Q Test Lead at Amgen in Thousand Oaks for state-of-art Single-Use Technology Manufacturing Facility• Establish project controls to support Commissioning & Qualification of Single-Use facility including document review checklists and KPI tracking• Interview and vet potential team members for fit and technical knowledge• Draft and Execute Receipt Verifications, Installation Verifications, Functional Tests, Performance Qualifications including Traceability Matrices and Summary Reports for Utilities, Manufacturing Equipment, and Support Equipment• Review of User Requirement Specifications and Risk Assessments

Automation Engineering Test Lead at Genentech in Vacaville, for CCP2 new product manufacture.• Building of team to complete Automation testing (S88 Standard Implementation) including review of resumes, on-boarding, work /schedule / staffing plan alignment, creation of training guides, updates to pre-approve and post-review checklists, and updates to peer review process• Project Management and Test Generation Lead for Automation C & Q of a new drug product• Generation, Review, and Execution of test protocols• Creation of ETMs (traceability matrix) for each unit class • Tracking of each test in project database (ITM)• Updating SOPs to support test plan• Weekly report of team metrics• Additional site automation infrastructure testing as required

Sr. Validation Consultant for Pharmaceutical and Medical Device Projects.Project Manger of IT Systems at Bayer Health Care in Berkeley, California for 85,000 sq. ft. QC Laboratory.Responsible for commissioning and qualification of site network, process control network, BAS (Siemens), SCADA (FourStep/iFix), LIMS (Sapphire), Wireless EM system (MODA), and a wireless CTE monitoring system (Rees).Project Management of Gas Piping and VFD Commissioning at UC Davis Kemper Hall Cleanroom Renovation.Responsible for construction and test status to project PM.

Responsible for all aspects of SQA group (staffing, leading, and developing teams, department vision, scheduling and budgeting of equipment and activities, SOPs, training plans, training, risk assessment, change management, compliance, audit defense, and testing strategies)

Managed team of five test engineers for cleaning validation and equipment validation of manufacturing suite(s). Project management of > $1,000,000 budget. Proposal writing, business development. Computer system validation.

Computer System Validation Expert

Managed a staff of four production specialists as a Lead for a state of the art Sterile Filling & Freeze-drying start-up facility to meet project goals and multiple deadlines.

Focus in micro-machines and robotics