Consultant, Kevin Kennedy Associates, Inc.
Provides expertise in business development and project management to a vast variety of clients.
Business Development / Research, consulting firm
Worked with team to research creation and feasibility of firm’s proposed incorporation of minority-owned 8(a) and foundation 501(c)(3) entities to focus on green supply chain solutions. Includes assistance to draft mission statement, identify sources of funding for start-up capital, originate projects, locate subject matter experts from industry and academia for consultant roster, and create organizational processes and procedures. Assisted President of firm complete foundation funded study on 3Rd-Party Logistics and Infrastructure Development multi-national corporations - Asia, Europe, Latin America, GCC focus - assess entry into markets, risk factors, financial investment, labor, and corporate social responsibility.
Associate Consultant, Becker & Associates Consulting: Colorado Springs, CO
Program Manager on engagement cardiovascular and laser manufacturer to launch Global Program & Process Management (GPPM) initiative. Initial engagement outcomes are one factor for current 2010, 150% rise in client stock price since March 2009 kick-off. Project scope to enhance quality system and support domestic, Asian, European, Latin American, and Middle Eastern growth by a factor of 2-3x’s current revenue with improved operational efficiency and compliancy with US Food & Drug Administration (FDA) and other competent authorities. Management of 45-50 person subject matter experts and client resources through pre-implementation phase identifying high priority risks (Warning Letter) within corrective and preventive action (CAPA), design, documentation, and material departments; including status data presentations. Responsible for deliverables including creation of project plans; provide teams with necessary tools and information; report project metrics to senior management, Steering Committee, and Board of Directors; keep timeline and milestones on-track; and maintain within $1 million project budget. Ensure initial stage of project is scalable to business development efforts for firm, future integration of additional teams that encompass full scope of FDA Quality System and Current Good Manufacturing Practices (CGMP) required for product development and maintaining project goals.
Senior Associate, Quintiles Consulting: Medolla, Italy; Abingdon, England; Abbott Park, IL; Rockville, MD; San Diego, CA
On-site program management and engagement development throughout tenure at Quintiles, working with Abbott Laboratories, Cardinal Health, Gambro, Johnson & Johnson, and other Fortune 500 and private device manufacturing clients to address non-compliant FDA issues. Managed and co-managed core teams ranging from 4–120 members to ensure quality system revisions addressed compliance gaps, prepared project records to support FDA audits for product re-entry into market and new product launch representing over $1.5 billion of revenue for clients. Co-managed consultant and client personnel from Germany, Italy, Mexico, Sweden, UK, & US on engagement to remediate manufacturing and safety risks negatively impacting $1 billion revenue stream and market share for dialysis manufacturer. As a result client regained regulatory and legal compliance in US market and FDA import ban lifted, enabling Swedish private equity owners to determine investment strategies for compliant divisions and re-introduce products into North America. Maintained client relationships; coordinated site audits to track progress of closing non-compliant gaps; assist with project timeline between client, consultants, and legal counsel (compliance, regulatory, legal milestones, decisions and actions); and communicated corrective activities to senior management and regulatory competent authorities via reports and shared dashboard solutions. Reviewed all past and current project management documentation to create Project Management Toolkit for Medical Device and Pharmaceutical Practices, including project reporting methods. Generate and follow-up leads for senior-level bioresearch and medical device recruitment.
Business Development Manager / Program Manager (US Integration & Client Relationships), Borderlinx: Brussels, Belgium; Fairfax, VA
Created US penetration strategy for cross-border e-commerce start-up and engaged self-generated pipeline of 350 merchants. Presented service proposition to potential clients and review contracts. Signed 1st integrated US account enabling client to sell products in EU. Assisted with P&L and price modeling, market penetration and service mix analysis leading to Asia launch with Citibank, managed RFP response to publicly listed merchant resulting in Borderlinx positioned as one of two shortlisted companies (out of nine) for merchant’s international e-commerce launch. Researched competitor offerings, liaised with UK & Belgian-based senior management, service providers, and clients to ensure service objectives satisfied. Helped set business framework with shipping hubs for market launches, including parts of the Middle East. Increased company’s brand among US merchants and managed affiliate portfolio listings to meet foreign consumer demand and increase company’s shipping volume and top line revenue.
Vietnam Business Development Manager, Skaarup Group, Halter Marine Group: Hanoi, Vietnam
Managed post-trade embargo commercial entry for shipbuilding and shipping services company, established strategic local, regional (Hong Kong, Japan, Singapore), legal, and government alliances. Guided completion of milestone export credit application between Dutch and Vietnamese Governments for proposed $25 million containership project to expand national shipping line and improve shipbuilding capabilities of Vietnam’s largest shipbuilder (primary local partner). Helped negotiate and prepare $2 million maritime service consulting joint venture with local partner’s financing subsidiary. Pursued strategic projects with PetroVietnam for supply of oil rigs, tankers, and new shipyard construction in Southern Vietnam to support oil and gas industry valued at over $200 million; Ministry of Defense for patrol boats and shipyard upgrades valued over $80 million. Monitored trade policies, business development targets, and created US agency role for local partner.
Program Associate, South-East Consortium for International Development (SECID): Washington, D.C.
Prepared proposals and recruited personnel to generate over $22 million of new business from US Agency for International Development (USAID-Senegal) and US Information Agency (USIA-Vietnam), including World Bank and Asian Development Bank RFP responses.
