Tom Glenn Email and Phone Number

Work with Life Sciences and Pharmaceutical clients to deliver best-in-class governance, business and technology consulting services for manufacturing-related projects. My responsibilities include P/L for the practice, Project and Program Management. The manufacturing practice focuses in ERP, MES, PAT, CRM, supply chain and eBusiness applications. I have managed software development projects utilizing traditional and iterative methodologies, and skilled in FDA compliance issues, GMP, ePedigree, Global Product Serialization and Software Validation. I provide strategy consulting services in ePedigree, Global Product Serialization and business process improvements related to data sharing, EDI, and partner collaboration through extended trading partners collaboration. The Manufacturing Practice has partner with Best-of-Breed applications like ELAN MES, SAP, QAD, and AEGIS MI applications.

Provide pre-sales support for the sales team. Develop Business relationships with customers by educating the customer on e-Pedigree legislation and how the current laws impact Pharmaceutical Manufacturers. Responsible for Product demonstrations and completion of RFP’s. Established the RFP process within the organization to respond to RFP’s, and ensure the responses represented to capabilities of the SupplyScape ePedigree application. Performed 4 paid five day site assessments to determine customer’s readiness for California ePedgree law and their readiness for product serialization. Project lead for the Strategic consulting work with TAP for business value around trade financials. Participated in the Strategic consulting work with HOSPIRA for Electronic pedigree and serialization. Developed demo script for the Nexus release of the SupplyScape product for training of the Sales Engineers.

Provide pre-sales support responsibilities including demonstrating the features and benefits of the product and comparing it to those of competitor's products; preparing and delivering product presentations to technical and management personnel; communicating with sales and product management teams regarding customer initiatives. Provide on-site support and product installation; integrating prototypes using the product for evaluation purposes; handling technical presentations at trade shows and conferences; identifying additional client requirements; ensuring proactive communications with customers to ensure customer satisfaction. An in-depth understanding of electronic commerce and EDI as well as an awareness of industry trends. Excellent communications skills; commitment to quality service and process improvement; professional presentation skills; self-starter; cooperative attitude; team player; ability and willingness to travel.

Understand the business needs of the international sales offices that will be using MFG/PRO and the Business objectives they are looking to meet. Work with the country Management to understand emerging needs, new product introductions and business/country specific product distribution issues. Ensure there is a support model in place in each country with appropriate localizations, and that there is an effective way to reach out to QAD to provide support and stay a breast of country specific issues. Maintain awareness of MFG/PRO application and infrastructure strategy and the impact to the countries/regions of decisions on that strategy. Manage the implementations using Genzyme IT and International Groups Project Management Methodology. Follow the appropriate application and infrastructure standards and policies, working to assure they are affective. Use the Business Solution design and Project Scope statement to ensure implementation and upgrade meet the business requirements. Ensure that unmet business needs are understood, surfaced, and prioritized. Manage and schedule phase II+ implementations, involving the QAD country offices to meet Genzyme Sales office country functional needs. Provide an effective Project communication plan to keep everyone on board with the project. Successfully implement projects and initiatives working with a business cross functional teams within time and cost constraints. Provide the first line of support for technical and functional issues that can not be addressed by a country. Develop Key Performance indicators with International Management and report on them to an agreed schedule. Regularly meet with the country management team and key users to stay in touch with business needs and ensure communication and confidence with all parties.

Responsible for managing all aspects of validation projects and services around the IOQ and PQ services. This includes developing, writing, and executing Installation and Operational Qualification protocols for NuGenesis ARCHIVE and UNIFY / VISION products. Develop and writing Performance Qualification protocols for NuGenesis ARCHIVE and UNIFY / VISION products. Write customer System Design Specifications and Requirements Traceability Matrixes for NuGenesis ARCHIVE and UNIFY / VISION products. Training internal and field personnel on compliance, validation methodologies and planning, execution of IOQ protocols, and validation service delivery. Deliver industry presentations and Web Seminars on COTS validation strategies.

Knowledge of cGMP, especially in the areas of computer or related systems use, and documentation procedures. Thorough knowledge and understanding of the Software Development Life Cycle approach to computer systems development. Well-versed in the principles of general validation activities, including Requirements, Design, Installation Qualification, Operational Qualification and Performance Qualification. Provide leadership and expertise by developing validation strategies and providing a variety of validation services. These services include the creation and execution of master validation plans and test protocols as well as 21 CFR Part 11 assessments and compliance plans. Responsibilities include generating validation protocols, executing, testing and summarizing validation results, and revalidation and change control programs pertaining to automated/computer systems in accordance with regulatory guidelines. Managing validation efforts to plan and budget. Experienced Validating MFG/PRO, NuGenesis, SAP, RIMS WHMS, Eagle Bar Coding, manufacturing equipment, and LAN/WAN infrastructures. Experience with seeCommerce seeChain applications, and Hologix RFP software.

Work closely with Sales Executives and potential customers to match those customers' requirements with the company's web-centric analytical applications. Responsible for examining a prospect's supply chain and identifying value that the prospect can realize through the purchase and implementation. Conduct value analyses on large accounts and present findings to executives. Performing tasks such as, interviewing clients, apply SeeChain value to various industries, lead solution demonstration and definition, and lead the final solution and value presentation to the prospect. Maintain expertise in the SeeChain applications and solutions. Creation of value & solution presentations. Participate in trade shows and other marketing events by demonstrating SeeChain and making focused presentations on product value. Provide feedback to Product Management regarding future solution requirements and definition. Participate in performing analysis of competitors; formulate competitive strategies.

Demonstrate Attricom through Order Capture, Procurement, Attribute Search Capabilities, and Managed Negotiation capabilities. Provide information gathering and the creation of presentation materials and proposal information for various markets/verticals. Software demonstrations for all public and private vertical and horizontal markets. Assist in sales account strategies and overall sales process. Assist in setting and implementing account strategies. Provide overall technical knowledge to the sales process. Understand and communicate, in detail, product features, functions, capabilities to prospects and customers. Responsible for examining a prospect's supply chain and identifying value that the prospect can realize through the purchase and implementation. Provide technical presentations to all enterprise levels - Team Sales Approach. Coordinate with Professional Services regarding the technical requirements of the prospects and customers. Product management inputs for Net Market Maker and vertical industries (i.e. Metals, Chemicals, Paper, Advertising, Logistics, etc.)

Provide pre-sales support and assist with sales activities and account management with Tier 1 accounts. Evaluate and complete RFP’s. Prepare client specific data for pre-sales demonstrations. Present demonstration data to client project teams in the areas of Manufacturing, Distribution, Financial, and Supply Chain modules of MFG/PRO. Conduct two-day business value assessments to enable clients to realize full value from the MFG/PRO medical applications. Provide post sales project management for client implementations. Coordinated multi-site, multi-currency, and multi-language project management for QAD’s largest medical customers. Act as point person between clients and QAD business partners during implementations. Managed accounts domestically, and internationally. Supported accounts like St. Jude Medical, CR Bard, Alza, and Stryker.

Plan and implement a Materials Control environment while following cGMP's. Implement a full-scale cGMP warehouse for supplies used in manufacturing bulk drug substance. Responsible for Materials Control, Receiving, Shipping, Purchasing, Production Planning, and Product Distribution. Create procedures and departmental policies while coordinating their implementation. Purchase raw materials from approved vendors used in the manufacturing. Create weekly inventory reports for manufacturing and control inventory levels for raw materials and components. Coordinate the transfer of bulk product between Cephalon and contract facilities, both domestic, and international. Coordinated the implementation of QAD, and implemented bar coding for inventory tracking. Conducted in conjunction with Quality Assurance vendor audits to qualify new, and re-approve old vendors. As manager I am responsible for all hiring, and training of new employees for the Materials department.

Implement a full-scale cGMP warehouse for supplies used in the manufacture of 3 clinical candidates. Design the flow of raw materials to ensure cGMP compliance. Responsible for the hiring and training of Materials Management personnel. Create procedures and departmental policies while coordinating their implementation. Coordinate the movement of Clinical supplies from Cytel and Contract Manufacturing site to various clinical sites. Work with Clinical and QA in establishing labeling requirements for European studies and US. Purchase raw materials from approved vendors used in the manufacturing of clinical drug product. Create weekly inventory reports for manufacturing and controlled inventory levels for raw materials and components.

Coordinate with Production Planning and Clinical research the drug requirements for clinical trials. Prepare monthly, quarterly and annual forecast summaries for clinical drug usage and discus drug availability. Generate and executed the clinical drug requests, including forecasted, unforecasted, and emergency drug requests. Coordinate with various CRA's the control of inventory at clinical sites and maintained sufficient inventory at Genentech. Initiate randomization and labeling requirements to the biostatisticians and Production Planning for blinded and open labelings. Assist CRA's in audits of Clinical sites for drug accountability. Coordinate the return of expired and unused Clinical supplies from various clinical sites. Establish procedures with Material Control for processing, accountability, and destruction of returned clinical supplies.