Luis Enrique Carro

Phone: 787-***-****, E-Mail: adic06@r.postjobfree.com

www.linkedin.com/in/luis-enrique-carro-2632129

PROFESSIONAL PROFILE

A versatile, accomplished, results-oriented, innovative hands on operational leader with a cross-functional global experience developing complex manufacturing networks and building winning teams. Possess management experiences in Biologics, Pharmaceuticals, and Medical Devices Sectors. Results-oriented who thrives in a dynamic, fast-paced while remaining focused and accountable with excellent communication skills, creative analytic problem solver with excellent team-building skills. Visionary leader specializing in turn-around assignments, mergers, and start-ups, with relentless resilience to quickly accomplish bottom-line results. Proven ability and record of envisioning and implementing process improvement, managing strategies and revamping business measures to increase readiness, efficiency and productivity.

KEY ACCOMPLISHMENTS

~ Executed Abbott Diagnostics Franchise COVID 19 scale up/start up new manufacturing facility in New York

~ Managed the technology transfer global merger of Abbott Vascular combination product in Costa Rica

~ Responsible for J&J PMO Ethicon Worldwide Sourcing Supply Chain remediation strategies in India

~ Executed medullar organization consolidations and site restructures reducing operational costs by $75M

~ Accountable of two manufacturing sites, 225 employee’s efficiencies managing over $55M yearly budget

Skill Areas: Program Management Vendor Management Tech Transfer Business Analysis Leadership Change Management Business Analysis Team Leadership Problem Solver Agile Project Management Agile Methodologies Leadership Strategic Planning Microsoft Excel Project Management Process Optimization Change Management Microsoft PowerPoint Microsoft Visio Engineering Quality Management Systems Business Development Strategic Planning Negotiation Customer Service Teamwork Public Speaking Analytical

PROFESSIONAL EXPERIENCE

Independent Consultant New York, India, Costa Rica, San Diego and San Francisco (Nov 2016- Present)

Senior Project/Program Manager Consultant Industry Leader in Regulatory Compliance, Product Introductions/Transfers, Sites Consolidations and Remediation’s.

Designed and deployed three major work streams for Abbott Diagnostics COVID 19 new start up facility in Syracuse, NY to supply worldwide testing demand with their combination medical device test kit. Responsible in charge of creating a Team of experts to support and execute the fully integrated Master Validation Plan strategy. Developed/executed with the Team over 100 protocols (IQ/OQ/PQ’s) for a Laboratory, molecular buffers and solutions filling/mixing automation validation, Lyophilizers process/production validations and all start-ups equipment’s qualifications. Performed readiness for the technical manufacturing of sterile reagents manufacturing areas, operational/commercial full compliance and manufacturing packaging validations.

Driver and accountable of the design/execution of Abbott Vascular Master Transfer Plan in Costa Rica. Responsible for the functional area’s transfer execution completion, continuously managing and evaluating upcoming risks, raising impacting issues, clearing bottlenecks, holding accountability, and always able to mitigate with a plan B (or C) to assure timely/on budget commitments, always exceeding Sponsors Expectations.

Responsible for all functional area’s and remediation activities of the sourcing Work Streams for J&J Ethicon Operations in India, continuously managing resources, evaluating risks, executed key supplier audits and multiple product movements to assure timely/on budget. Exceeded Work Streams Sponsors Expectations.

Directed Brazil product transfer, MDR-EU assessment and efforts, SAP operational integration, QMS remediations for Line Controls, Documentation and Complaints Systems, product validations and characterization partnering with R&D and facilitated discussions of the J&J organization’s sourcing strategy.

Established and executed the PMO program governance and resource management tools. Created a Master Communication Plan to update J&J senior management on critical deliverables. Implemented key facilities improvements and business best practices preventing the expense of over $3.5 M/year.

ZIMMER-BIOMET MEDICAL DEVICES MANUFACTURING US (Jan 2013 - Oct 2016)

Multi-Site Manufacturing Operations Manager Zimmer Biomet produces Medical Devices including hips, knees, and trauma devices, to restore patient’s health.

In charge of all operational business, including staffing, site improvements execution, plus budget preparations. Directed 9 engineers, 6 supervisors, 55 contractors, and over 225 direct employees in a regulated environment.

Orchestrated all business development efforts and responsible for the design and deployment of key initiatives to improve product and process quality to mitigate various 483’s given by the Agency, UDI Implementation completed for the site, supported the preparation and facilitation of FDA regulatory inspections, backroom readiness and document reviews. As part of the quality remediation efforts reviewed draft and approved over 200 validation protocols for execution and final reports.

Managed all manufacturing operations, daily Site production meetings, reduced manufacturing material scrap by 80%, Non-Conformances by 50%, and productivity was increased in the packaging area by 75%.

Engaged as a cross-functional leader all three shifts including the KPI’s monthly meetings with all personnel and one on ones on a weekly basis with all the exempt team managing an operational P&L of $55M.

Executed with QA breakthrough reduction in-process testing, increasing manufacturing capacity by 40% and reduced costs of labor/materials by $2.5M/year in my first 12 months in the position.

Government Development Bank, Inc. US (Jan 2011 – Dec 2012)

Senior Project Manager/Governor Advisor

GDB is in charge of developing financial strategies for the Commonwealth of PR and all Government Agencies.

Responsible for the design, development, and implementation of the Government Performance Dashboard tool design, deployment within 10 agencies and KPI metrics to track Governor Fiscal Agency goals/objectives.

Supervised 7 Project Managers and other professionals to achieve an excellent record in new technology introduction, savings $15M/year. Managed 9 Consulting firms to improve costs and efficiencies, reducing overall government structures my means of consolidations and shared services creation.

Developed and deployed the first and more productive on-line IT government initiative that provided citizens on-line self-serve services reducing costs by $65M/year in labor/materials. These initiatives included multiple platforms to communicate and provide information to citizens for 125 government agencies services including payments and the retrieval of certificates to confirm citizen compliance with government requirements.

JOHNSON & JOHNSON, ORTHO BIOLOGICS BIOTECH US (Feb 2005 – Dec 2010)

Site Continuous Improvement Black BeltJohnson & Johnson is an American multinational that develops biologics, pharmaceuticals and medical devices.

Led Site Performance Improvement Strategy execution to manufacture efficiently biologic large molecules.

Designed the Site Lean Six Sigma transformational roadmap to transform the culture through continuous improvement kaizens, ideas program, 5S, rewarding systems, and Green/Black Belt Certifications, catapulting the manufacturing site bottom-line results and people accountability and creating additional site capabilities.

Directed cross-functional Teams and managed the efforts to drive a flawless continuous improvement transformation with the implementation of innovative strategies and tactics to reduce organizational costs by $4.4M/year. Provided daily/weekly leadership direction to deploy the Roadmap with the creation of multiple automated dashboards and a strategic communication plan to enhance corporate visibility.

MERCK PHARMACEUTICAL PRODUCTS LLC US (March 2002 – Jan 2005)

Project Manager – Consent Decree Remediation Merck Corporation is a United States-based pharmaceutical company.

Directed ten functional teams with 8 Project Managers in a global strategic alignment for the Consent Decree deliverables as part of the cGMP Workplan Program between various manufacturing locations to achieve Regulatory Compliance of all Quality Management Systems to manufacture small molecules, surpassing FDA requirements and complied fully with the FDA Non-Compliance findings as part of the Consent Decree.

Created project deliverables for each FDA Significant Step and complied fully on time/on budget on each of the 125 projects in scope and supported the preparation and facilitation of FDA regulatory inspections and reviews.

Designed, managed and tracked with the Site Leadership key Quality Management Systems Significant Steps enhancements projects to mitigate all gaps found in multiple systems including Contractors & Suppliers, Complaints, Investigations, Regulatory Audits, Production Control Training, Documentation, API Manufacturing, Materials & Sampling, Sterile Manufacturing, Technology transfer, Process Validations,, Laboratory Operations, Access Control, Equipment and Facilities and Quality Management where it was required develop and implement all improvements to prevent $15k FDA daily fines for any delays.

Accountable and owner of the Site Performance Project Management Dashboard for the Consent Decree and executed the Leadership communication in a daily, weekly and monthly basics as required by the Agency.

PROFESSIONAL DEVELOPMENT & CREDENTIALS

Education

MBA, Technology Management, Phoenix University, San Juan, Puerto Rico

Bachelor in Science, Industrial Engineering, Louisiana State University, Baton Rouge, Louisiana

Certifications

Project Management Professional certified (PMP)

Lean Six Sigma Black Belt certified from Johnson & Johnson (LSSBB)

Six Sigma Black Belt certified from General Electric (SSBB)

Project Management Risk Management Professional Certification – In Progress

Kaizen Promotion Office (KPO) Certified Manager by the TBM Consulting Group

Certified Kaizen Execution Train the Trainer Certified by the TBM Consulting Group

Process Innovation Leadership Award – Johnson & Johnson

Continuous Improvement Prize and Lean Corporate Advisor/Assessor Certified by Johnson & Johnson

Powerless to Powerful, Managing Globally and Client Management Certificates

Registered Project Manager Officer Global Alliance member

OEE & TPM Certificates from Johnson & Johnson

Member of the Manufacturing Engineers Association

Member of the Operational Excellence Institute

Agile Training and Certification

Languages

English – Spanish – Portuguese - Mandarin

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