Establish and direct Coda’s Quality Analytical Services Division. Provide expertise for customer adherence to the FDA’s cGMPs, Title 21 CFR, parts 58, 820, 210, 211, 600-680 and 11, ISO and DEA regulations, Eudralex Volume 4 GMP, Part 1, Chapters 1, 2, 3 and 4. Manage and oversee client projects for quality, efficiency, and technical accuracy. Oversee and review all projects and timelines for employees and clients. Guide the development and direction of employees. Create corporate technical and operating policies and procedures. Analyze client quality control systems for FDA regulatory compliance.

Sr. level project management, resource supervision and team builder. Validation, training, facility start up, facility planning, corrective/preventative action program management. Providing senior level consulting services. Independent definition of project plans and execution; team based participation in validation, technical writing and quality system infrastructure projects. Status reporting; internally to Coda Corp USA's executive team and client project leads. Resource allocation, project management, issue resolution and process development and facilitation. Provision of compliance guidance for clients with regard to with FDA’s cGMPs, Title 21 CFR, parts 600 – 680, 820, 210, 211, and 11, CBER, CDER, and ISO, regulations. Key Achievements• Project Management• Project Plan Definition; Facility Start-up, Commercialization - Submission• Project Progress Tracking, and Reporting• Technical Writing• Batch Record Creation/Modification• Budget Management• CAPA Management• Supplier Quality• Developed and maintained client relationships including: • Tunnell Consulting • Doherty Validation Services • Allergan (multiple sites and projects) • Boston Scientific (multiple sites and projects) • Genzyme • Sanofi - Pasteur • Bausch and Lomb • Pfizer, research • Merck Research Laboratories • Pall Scientific and Laboratory Services

Project details are considered proprietary to clients and confidential however, general responsibilities included: Participation in the development and implementation of validation strategy and approach, identification and documentation of multi-site requirements/ specifications, test protocol preparation, general project management, internal and external status communication.Project scheduling, metric development, issue faciltiation.Biologics and Pharma experience.Clients Include; Coda Corp USATunnell ConsultingDoherty Validation ServicesSanofi PasteurBoston ScientificGenzyme

Managed a 3-site implementation (Ireland, Brazil, USA) of an integrated quality system including, LIMS interfaced to SAP, Millennium CDS and analytical laboratory equipment.• Prepared global capital expenditure justification• Prepared global budget and resource requirements• Prepared global timelines and Gannt charts• Coordinated each site project with local project managers• Tracked progress on goals, maintained global timelines and created monthly updates for senior world wide management• Reviewed and approved local URS documentation• Evaluated local URS documents in order to prepare a Global URS Gap Analysis• Managed the local Wesport team implementation/validation team of 8, Member of the local Sr. Management team

Responsibilities included: Management of the upgrade of existing LIMS system to a Windows based system. Automated the transfer of data to the LIMS, from laboratory equipment. The project management responsibilities for this project, while similar to those outlined in the project management section above, focused on data management for a stability and validation laboratory as opposed to a QC Laboratory.

Management responsibilities included: Yearly reviews and pay assessments for 10 team members, resources capabilities assessment and task delegation. Projects/Programs Managed/Directed Included; SRS (Secondary Reference Standards) Project Bulk Drug Substances ProjectOut Of Specification (O.O.S.) ProgramStability Testing Program

Responsibilities included: • Assisted in the design of a new laboratory, designed for both QC and ETC departments• Responsible for the controlled transfer of all stability samples to new stability chambers • Ensured that all equipment moved to the new facility was properly calibrated • Involved in the method development / transfer for a number of new products including creams and gels• Initiated a new procedure for prioritizing and assigning work load in the laboratory.