LEONEL PEREZ
San Juan
Summary
Highly skilled and globally experienced professional with over 14 years of success driving large-scale projects and operations across the medical device, pharmaceutical, and consumer goods industries. Demonstrated expertise in manufacturing operations, quality, CSV, R&D, engineering, and validations, with a proven ability to lead cross-functional, multicultural teams across the USA, Europe, and Asia. Adept at managing product transfers, new product introductions, regulatory compliance, and addressing consent decrees and warning letters. Recognized for strategic decision-making, problem-solving, and delivering measurable business outcomes. Fluent in Spanish and English, with strong leadership, communication, and team-building capabilities.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Principal Quality Engineer
Medtronic
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 ISO13485 and FDA21 CFR Part820, 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 100% pass rate.
- Developed and executed corrective and preventive action (CAPA) plans to address and resolve product quality issues, improving customer satisfaction by 30%.
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Implemented process improvements based on Lean Six Sigma methodologies, resulting in reduced waste and increased efficiency.
- Enhanced product quality by implementing rigorous inspection procedures and conducting thorough root cause analysis.
- Conducted detailed audits to ensure adherence to ISO 9001 standards, maintaining a high level of compliance throughout the organization.
- Collaborated with external auditors during annual reviews, ensuring a seamless audit process with minimal findings or discrepancies noted.
- Implemented new strategies to reduce costs and improve efficiency of engineering team.
- Accomplished multiple tasks within established timeframes.
- Managed and motivated employees to be productive and engaged in work.
Director Quality Assurance/Control
Skalar Pharma
09.2022 - 02.2024
- 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
- 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 Development, 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
- Lead ISO certifications readiness
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Cross-trained existing employees to maximize team agility and performance.
- Reduced operational costs through comprehensive process improvement initiatives and resource management.
Senior Quality Manager
Romark Global Pharma
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, consolidated23 training requirements to three, and reduced the onboarding process for personnel from three months to three weeks
- Collaborated with the FDA to ensure compliance with regulatory requirements for drug products, focusing on Finished Drug Formulations (FDF)
- Assisted in the preparation and submission of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)
- 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 and comply with regulations part210 and211
- 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 approval15% timing less of established
Senior Quality Project Manager
Johnson & Johnson Surgical Vision
10.2017 - 02.2020
- Lead of Global Quality Assurance Computer System Validation (CSV)project for the medical device manufacturing surgical subdivision, overseeing seven plants and directing a $12 million operational and remediation project budget
- Responsible for managing a team of over 70 employees, both direct and indirect, to remediate Manufacturing and Laboratory equipment
- Oversaw CSV, process automation, and computer systems validation across production, laboratories, facilities areas, ensuring 100% product quality and compliance.
- Managed strategies to detect defects in the CSV system to comply with 21 CFR11 and CFR820
- 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 70%, data collection time decreased, systems reliability increased from 60% to 75%, expenses reduced by 30%, and customer satisfaction enhanced through emerging technologies and effective quality systems
- Met project deadlines without sacrificing build quality or workplace safety.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Subject Matter Expert in developing global change control strategies
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for large projects.
Manufacturing Manager
Mylan, LLC.
04.2014 - 08.2017
- Managed manufacturing support with over 400 associates and 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, engineering design, complaints, and studies of the Manufacturing area
- Found solutions to enhance the manufacturing process of products the cost
- Created and delivered development and performance improvement programs
- Reduce 75% Standard Operating Procedure due to simplification and optimization strategy
- Support the team in FDA inspections, which resulted in Zero observations
- 98% resolved CAPA on time and Periodic reviews
- Around +300 CAPA were completed
- 95%> 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
- Conducted root cause analysis investigations to identify areas for improvement in manufacturing processes, leading to increased efficiency and fewer defects.
Senior Engineer (Consultant)
Johnson & Johnson (Contractor)
05.2010 - 04.2014
- Perform Installation and Operation Qualification (IOQ) and validation documents.
- Experience working with Consent Decree and 483 FDA observations.
- Lead and execute protocols comply with 21CFR PART11.
- Analyze challenges of alarms, input, output, software, and screens in the manufacturing and packaging areas to minimize 90% error process flow.
- 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
- 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.
- 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 improvement and approval process.
- Improved project efficiency by streamlining engineering processes and implementing innovative solutions.
- Enforced rules and regulations to keep working environment safe.
- Wrote, reviewed and edited technical document in accordance with template requirements.
- Participated in formal internal design reviews of proposed products and components.
- Reduced project completion time with efficient resource allocation and effective communication strategies.
Education
Doctorate in Mechanical Engineering (Ph.D.) - Fluid and Process Thermal
Polytechnic University of Puerto Rico
San Juan, PR01.2026
Master of Science (MS) - Manufacturing Engineering, Process Pharmaceutical
Polytechnic University of Puerto Rico
San Juan, PR06.2014
Bachelor of Science (BS) - Chemical Engineering
Polytechnic University of Puerto Rico
San Juan, PR06.2011
Skills
- Strategic Planning & Execution
- Process engineering
- Lean & Six Sigma
- New Product Introduction
- Portfolio Management
- Manufacturing strategic
- Cross-Functional Collaboration
- Remediations
- Leadership Capabilities
- Organization Development
- QA/QS/QC operations
- Project Management/A3
- Attention to Detail
- Technical Writing
- Corrective Action Planning
- Quality processes
- Non-conforming material reports
- Root-cause analysis
- Control plan development
- Six sigma methodologies
Certification
- Green Belt Certification, Lean Manufacturing, Lean Six Sigma, Advanced Manufacturing Certification, and Minitab
- Lead Auditor Project Management, Trackwise, Agile, and FactoryWorks, Yellow belt Certification
- FMEA, Kaizen and Food Safety System Certification (FSSC22000),PowerBI
- FDA Complaint Best Practices, Project Management (PMP) and Minitab
- Data integrity FDA, SAP, ASQ and MDR EU, Wonderware, VMWare and Empower
Timeline
Principal Quality Engineer
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 Manager
Mylan, LLC.
04.2014 - 08.2017
Senior Engineer (Consultant)
Johnson & Johnson (Contractor)
05.2010 - 04.2014
Master of Science (MS) - Manufacturing Engineering, Process Pharmaceutical
Polytechnic University of Puerto Rico
Bachelor of Science (BS) - Chemical Engineering
Polytechnic University of Puerto Rico
Doctorate in Mechanical Engineering (Ph.D.) - Fluid and Process Thermal
Polytechnic University of Puerto Rico
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