Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

LEONEL PEREZ

San Juan,Puerto Rico

Summary

Highly experienced professional with global exposure and an outstanding record for driving large-scale projects that grow business and organizational capacity for multinational medical devices, consumer goods, and pharmaceutical companies with multimillion-dollar revenues. A leader with Fourteen (14) years’ experience with a strong background in Manufacturing, Quality, CSV, R&D, Engineering, and Validations. Skilled in research and development, product transfer, and third-party management, I have successfully executed strategies and tactical programs to achieve business objectives. My proactive leadership includes start-up experience, product transfers, and new product introductions. Effective communication and leader of global and local business strategy to small and large groups. Experience of managing team in USA, Netherlands, Sweden, Malaysia and China to support all activities related to Quality, Manufacturing, Validation and 21CFR PART 11. Expert in reducing scrap and improving yield through the application of process excellence tools and methodologies. As a leader supporting all business segments in advancing product pipelines, it enhances safety product and quality. Strong experience working with Consent Decree and Warning Letters. Visionary, creative thinker, problem solver, and strategic decision maker flexible in responding to constantly changing organizational and market demands with a focus on rapid detection. Fluent in Spanish and English.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Principal Quality Engineer/Quality Manager

Medtronic
Juncos, PR
02.2024 - Current
  • Lead a team of 10 quality assurance professionals in managing the quality control processes for Class II and III medical devices
  • Implemented and maintained QMS in compliance with ISO 13485 and FDA 21 CFR Part 820, resulting in a 25% reduction in non-conformance rates
  • 100% Execution and supporting CAPA on time
  • Spearheaded the successful completion of internal and external audits, achieving a 100% pass rate
  • Developed and executed corrective and preventive action (CAPA) plans to address and resolve product quality issues, improving customer satisfaction by 30%
  • Collaborated with R&D and manufacturing teams to ensure seamless integration of quality requirements in product design and production processes
  • Conducted thorough risk assessments and failure mode effects analysis (FMEA) to identify potential quality issues early in the product lifecycle
  • Managed supplier quality performance, including audits and assessments, to ensure adherence to company standards and regulatory requirements
  • Led cross-functional teams in root cause analysis and implementation of corrective actions, reducing product defect rates by 20%
  • Developed and delivered training programs on quality standards and best practices to engineering and production staff

Director Quality Assurance/Control

Skalar Pharma
Guayama, PR
09.2022 - 02.2024
  • As the Head of Quality Assurance, Quality Control, and Validation, I spearheaded the demand management strategy for the Plant Startup, establishing comprehensive quality system programs and laboratory from the ground up
  • Developed a robust strategy to ensure the site met GMP standards and complied with FDA regulations
  • Oversaw QA/QC, Validation, and Regulatory Affairs teams within the Skalar group, leading a team of 50 employees at the QA API manufacturing site and navigating a complex matrix organization
  • Reporting directly to the CEO, played a crucial role in the Plant Startup initiative and successfully launched a new project that delivered outstanding results
  • Responsible for the Site's overall QA program, Quality Systems, Compliance, Audits, Training, and Operation, integrating products and processes with effective results to improve processes and support new product strategies in developed
  • Leader in the creation of the entire quality compliance, quality supplier, and quality system management program (CAPA, Investigation and Change control) for the startup plant
  • 100% program were completed and audited with zero observations
  • Establish best-in-class quality goals, perform quality metrics trending, and apply problem-solving system improvements to meet these target levels of quality
  • Establish standards/metrics to facilitate exponential growth while adhering to quality standards and regulatory guidelines
  • Formulates and administers policies and standard operations procedures (SOPs) relating to the QA function and the quality management system
  • Worked directly with the FDA registration site and developed a validation strategy in which around +400 validation documents were created and executed effectively
  • 100% on time
  • Interface with senior leaders and decision-makers to create short and long-term plans and remediations
  • Lead as QA/QC to participate in CDMO and CMO technology transfer and develop a molecule
  • 95% of the efficiency of the accurate molecule
  • Led the process to obtain permits from the Department of Health and DEA, successfully passing the audit with zero observations and securing the necessary licenses
  • Ensure Site’s compliance and regulatory high-performance level meeting the different regulatory agencies requirements
  • Establish and follow up on the Site’s Quality compliance objectives and metrics through the Site Quality Review Board
  • Responsible for the development and implementation of initiatives for efficiency improvement and to assure fail-safe quality operations
  • Implementation A3 for operation excellence to saving cost operating

Senior Quality Manager

Romark Global Pharma
Manatí, PR
02.2020 - 09.2022
  • Directed strategies, programs, and plans in Puerto Rico, Tampa, and Belgium with three (3) plants
  • QA led in Research and development and Commercial oversees all site activities related to the production and guides the implementation
  • Work with brand products for the following treatments: Covid-19, Influenza, infection, and parasite
  • Work with the corporate business plan and set goals for the department to ensure that plan goals are met; communicate goals to the department staff; and initiate tools to measure the department’s success
  • Provided quality leadership defining short and long-term plans to maintain reliable quality systems aligned with new technologies, support expansion projects, process improvement, outsourcing, and cost reductions
  • A Led startup at Manatí, PR plant; completed under budget and smooth FDA approval
  • Support R&D process (PPQ), equipment, process ranges, engineering trials, feasibility, and formulation
  • Applied Kaizen principles and process improvements that mapped the training process, consolidated 23 training requirements to three, and reduced the onboarding process for personnel from three months to 4 weeks
  • Development of a more efficient process to evaluate new project proposals
  • CAPAs, Events, and Change control comply with +95% on time
  • Led the FDA strategy to approve a new product and manufacturing facility
  • The audit result with the auditors was zero observations, and we received certification to manufacture our installation and approve the product for the EU and US markets
  • QA Lead in the New Product Introduction (NPI) projects
  • Design strategy for the New Product Introduction (NPI) in which two (2) new products have been successfully transferred effectively with the record for the approval 15% timing less of established

Senior Quality Project Manager

Johnson & Johnson Surgical Vision
Puerto Rico and Netherlands
10.2017 - 02.2020
  • Managed Global QA CSV program medical device manufacturing surgical subdivision, with seven plants directing a $12MM operational project budget, and +70 staff employees in an FDA-regulated environment to remediate the Manufacturing and Laboratory equipment and CSV System
  • Expat in Netherlands as lead remediation CSV QA
  • Oversaw CSV, process automation, and computer systems validation across production, laboratories, facilities areas, ensuring 100% product quality and compliance
  • Led major projects including equipment and computer system validation, and significant expansions, delivering objectives within strict budgets of approximately $12 million
  • Managed strategies to detect defects in the CSV system to comply with 21 CFR Part 11, 210, 211, and 820
  • Provided direct leadership to the site Quality Management Representative (QMR) and Quality Systems Representative (QSR) for Electronic Quality Management Systems (EQMS) administration
  • 100% Support in strategies for the Software Development Life Cycle (SDLC) and supported cross-functional teams in making key decisions and crafting global strategic plans
  • Implemented Quality metrics and a new system to identify opportunities for improvement and measure operational, manufacturing, release, and service aspects, ensuring adherence to strict internal and regulatory guidelines
  • Supported FDA audits and regulatory inspections, representing sites on Data Integrity and compliance efforts
  • Managed a global remediation strategy for approximately 413 systems CSV, achieving zero observations during external audits and FDA inspections
  • Led initiatives to integrate Quality Management System (QMS) and Laboratory Quality Management System (LQMS) with best business practices, resulting in significant improvements: cycle time improved by 100%, order delivery lead time reduced by 80%, data collection time decreased, systems reliability increased from 60% to 75%, expenses reduced by 50%, and customer satisfaction enhanced through emerging technologies and effective quality systems
  • Subject Matter Expert in developing global change control strategies

Manufacturing Operations Manager

Mylan, LLC.
Caguas, PR
04.2014 - 08.2017
  • Managed manufacturing support with over 400 associates and 11 direct and indirect employees
  • Ensured production and quality goals through strategies delivering improvements in manufacturing operations, business management, supply chain integration, and regulatory compliance areas
  • Develop manufacturing projects that result in up to 60% savings
  • 100% Right the First Time in SOP’s effectiveness, which resulted in a reduction average related to the cycle time
  • Developed and established the structure to manage the introduction of up to six (6) new products concurrently at the site and 32 commercial generic products
  • Review and approve all documentation of validation, complaints, and studies of the Manufacturing area
  • Found solutions to enhance the manufacturing process of products at half the cost
  • Created and delivered development and performance improvement programs
  • Reduce 75% Standard Operating Procedure due to simplification and optimization strategy
  • Participated in and supported FDA inspections, which resulted in Zero observations
  • 97% resolved CAPA on time and Periodic reviews
  • Around +300 CAPA were completed
  • 98% on-time resolution in 63 projects related to optimization, qualification, and decommissioning of the equipment and process (Coaters, Blisters, Compressor, Encapsulation, V Blenders, Mixers, Vacuum Chambers, Fluid bed, Oven, and among others), which resulted in a cost saving of approximately >five (5) millions
  • Led large global scale projects, including managing the Batch Record Redesign Format Global project, which resulted in a reduction of 55% in human error, documentation, and entries
  • Reduction of 75% in review, approval, and coordination due to system implementation
  • Led project in yield improvement where use operational excellence tools
  • Revenue >4.5MM

Senior Engineer

McNeil Consumer Healthcare, Johnson & Johnson
Las Piedras, P.R.
05.2012 - 04.2014
  • Perform Installation and Operation Qualification (IOQ) and validation documents
  • Experience working with Consent Decree and 483 FDA observations with FDA
  • Analyze challenges of alarms, input, output, software, and screens in the manufacturing and packaging areas to minimize 90% error process flow and steps
  • Led to develop a strategy with manufacturing leaders, operators, quality oversight, mechanics, and product release managers to minimize product impact and discuss solutions
  • Investigated, documented, and followed up on Regulatory Corrective Actions assigned to multiple manufacturing areas and regulations for FDA
  • Manage a virtual environment machines project in the Data Center
  • (VMware)
  • Developed and executed computer system deliverables (VP, URS, FRS, Technical Specification, Traceability Matrix, IOQ, and reports)
  • Support member teams in two countries to plan and execute the $2MM VMWare project
  • Saved $150K on e-commerce virtual launch
  • Provided directions to employees, assigned cases, discussed findings, and assured timely delivery
  • Worked with Validation Summary Reports and routing documentation
  • Support (MES), Wonderware, and SCADA systems
  • Analyze challenges of alarms, input, output, software, and screens in the manufacturing and packaging areas to minimize 90% error process flow and steps
  • Worked with Validation Summary Reports and routing documentation
  • Support (MES), Wonderware, and SCADA systems
  • Design customizes program virtual infrastructure system
  • Saved +$500K on manufacturing releases and approval process
  • Minimize the investigation and CAPA
  • The product runs with the system, with no manual process

Education

Doctorate in Mechanical Engineering (Ph.D.) - Fluid and Process Thermal, Mechanical Engineering

Polytechnic University of Puerto Rico
San Juan, PR
01.2024

Master of Science (MS) - Manufacturing Engineering, Process Pharmaceutical

Polytechnic University of Puerto Rico
San Juan, PR
01.2014

Bachelor of Science (BS) - Chemical Engineering

Polytechnic University of Puerto Rico
San Juan, PR
01.2011

Skills

  • Strategic Planning & Execution
  • Process engineering
  • Lean & Six Sigma
  • New Product Introduction
  • Portfolio Management
  • Manufacturing
  • Cross-Functional Collaboration
  • Remediations
  • Leadership Capabilities
  • Organization Development
  • QA/QS/QC operations
  • Project Management/A3
  • Attention to Detail
  • Technical Writing
  • Corrective Action Planning

Certification

  • Lean Manufacturing
  • FMEA
  • FDA Complaint Best Practices
  • Data integrity FDA
  • Green Belt Certification
  • Lead Auditor Project Management
  • Advanced Manufacturing Certification
  • Kaizen
  • Project Management (PMP)
  • ASQ and MDR EU
  • Lean Six Sigma
  • Certification Practical Statistical Thinking using Minitab
  • Food Safety System Certification (FSSC22000)
  • Leader Auditor ISO9001 and 17025 Certification
  • Trackwise
  • Agile
  • SAP
  • Manufacturing Process
  • FactoryWork
  • Ross (Supply Chain)

Timeline

Principal Quality Engineer/Quality Manager

Medtronic
02.2024 - Current

Director Quality Assurance/Control

Skalar Pharma
09.2022 - 02.2024

Senior Quality Manager

Romark Global Pharma
02.2020 - 09.2022

Senior Quality Project Manager

Johnson & Johnson Surgical Vision
10.2017 - 02.2020

Manufacturing Operations Manager

Mylan, LLC.
04.2014 - 08.2017

Senior Engineer

McNeil Consumer Healthcare, Johnson & Johnson
05.2012 - 04.2014

Doctorate in Mechanical Engineering (Ph.D.) - Fluid and Process Thermal, Mechanical Engineering

Polytechnic University of Puerto Rico

Master of Science (MS) - Manufacturing Engineering, Process Pharmaceutical

Polytechnic University of Puerto Rico

Bachelor of Science (BS) - Chemical Engineering

Polytechnic University of Puerto Rico

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LEONEL PEREZ