Expert Details
CPG Quality Assurance & Compliance (cGMP/FDA Regulated Industries) & Industrial Microbiology
ID: 740785
Texas, USA
Expert has developed deep expertise spanning product supply and research & development functions, with particular strength in regulatory compliance across FDA cGMPs, Good Laboratory Practices, ISO standards, MHRA, EudraLex, and ICH requirements. Expert has worked across a broad range of consumer product categories, including beauty and cosmetics, over-the-counter drugs, pet food, and fabric/home care products. Expert is recognized as a subject matter expert in process improvement methodologies, including Lean Manufacturing, Six Sigma, microbiological controls, and HACCP-based food safety programs, as well as laboratory management, process controls, and validation practices.
Expert has particular strength in manufacturing crisis recovery, having successfully led robust recovery solutions during business shutdowns related to microbiological contamination events and significant quality incidents. Expert is described as a transformational, data-driven leader with a highly collaborative and business-oriented approach, with a strong passion for people development, building individual and team capability, and establishing new organizations. Expert is bilingual in Spanish and English.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1997 | Degree: BS | Subject: Industrial Microbiologist | Institution: Los Andes University Colombia |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2019 to 2025 | Employer: Estee Lauder | Title: Executive Director Global Quality R&D, Corporate Compliance & Technical Readiness for New Product Launch | Department: Research & Development |
Responsibilities:• Contributed to Product Supply and Research & Development functions, with regional experience across Latin America, Europe, and North America.• Provided expertise in FDA cGMP compliance, quality assurance, industrial microbiology, sanitary/engineering design, new product launch, and corporate quality management functions for beauty and cosmetics product categories. |
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| Years | Employer | Title | Department |
| Years: 2016 to 2019 | Employer: Procter & Gamble | Title: Senior Director North America QA Innovation & Start Up Beauty operations | Department: Quality Assurance |
Responsibilities:• Contributed to Product Supply and Research & Development functions, with regional experience across Latin America, Europe, and North America.• Provided expertise in FDA cGMP compliance, quality assurance, industrial microbiology, sanitary/engineering design, new product launch, and corporate quality management across beauty care, fabric and home care, paper, foods, and pet care product categories. |
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| Years | Employer | Title | Department |
| Years: 2011 to 2016 | Employer: Procter & Gamble | Title: Director E-IMEA region Industrial Microbiology/Food Safety | Department: Quality Assurance |
Responsibilities:• Launched a new regional QA organization ensuring Food Safety and regulatory compliance (FDA, MHRA, ICH) across 61 manufacturing sites (in-house and contract) spanning 5 core businesses; built and led a team of 9 regional auditors overseeing 35+ site-level resources.• Co-developed the region's Micro Control and Quality Strategy, and led multifunctional teams driving over $250 million in Clean Design improvements. • Implemented a formal micro auditing and CAPA system that eliminated 80% of critical micro risk areas and cut quality defects 20% annually; separately drove cleaning/sanitation redesigns generating $5 million in savings. • Led root cause investigations for contamination incidents and resulting preventive actions. • Co-authored global cleaning/sanitation standards saving 50% in downtime, water, and energy company-wide. • As part of the Corporate QA Microbiology team, authored 20+ policies and improved testing methods company-wide; implemented lean lab practices that raised productivity 10% across Europe and became a certified Lean Labs trainer. |
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| Years | Employer | Title | Department |
| Years: 2005 to 2011 | Employer: Procter & Gamble | Title: Director QA Manufacturing and Distribution for Fabric & Home Care | Department: Quality Assurance |
Responsibilities:• Served as QA Director for two major manufacturing facilities — the company's largest-volume detergent/fabric softener plant and a second complex, multi-category facility (air fresheners, cleaners, dish detergents) with Kosher and EPA regulatory requirements.• Drove $45 million in clean design capital investment and held direct accountability for product release decisions and a full validation program (formulation, facility, equipment) under cGMP standards. • Built the company's first consumer engagement center linking line operators to consumer insights; served as primary host for regulatory audits and inspections. • Managed the quality organization and lab operations, and led a lean manufacturing program (including Autonomous Maintenance); served as Quality Loss elimination lead, recovering $15 million over 3 years. |
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| Years | Employer | Title | Department |
| Years: 2000 to 2005 | Employer: Procter & Gamble | Title: Senior Manager North America region Industrial Microbiologist/Food Safety | Department: Quality Assurance |
Responsibilities:• Held microbiological compliance responsibility across 12 manufacturing sites (company and contract), pioneering the region's microbiological control ("Food Safety equivalent") systems.• Provided technical expertise on equipment, sanitation practices, validations, and testing methods; led complex contamination troubleshooting to minimize business losses. • Started up 7 microbiology labs, including hiring, onboarding, and facility/equipment design. Conducted integrated microbiological risk audits at each site and served as primary technical reviewer for clean design and food safety practice changes. |
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| Years | Employer | Title | Department |
| Years: 1997 to 2000 | Employer: Procter & Gamble | Title: Manager QC & Industrial Microbiologist for Beauty Operations | Department: Quality Assurance |
Responsibilities:• Held overall responsibility for the plant's microbiological control program ("Sanitation and Food Safety equivalent"), including HACCP analysis, sampling, monitoring, and CAPA development.• Managed the microbiology lab and its personnel's development/compliance, and ensured site-wide cGMP and sanitary design compliance. • Worked with surfactant suppliers and transporters to ensure microbial-free raw material delivery; became expert in troubleshooting complex contaminations. • In Mexico, supported sanitary design for a new in-house surfactant dilution operation serving Latin America, innovating ozone-based sanitation in place of chemical/heat methods. |
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Career Accomplishments
| Associations / Societies |
|---|
| • ISPE - International Society for Pharmaceutical Engineers • PCPC - Personal Care Products Council • ASQ - American Society for Quality • USP - US Pharmacopeia |
| Licenses / Certifications |
|---|
| • Certified IRCA GMP Auditor & Qualified Investigator (Root Cause Analysis) • Qualified Program Technical Manager • Qualified in Perigon Work Process Mapping techniques (Business Enterprise Mapping) • Six Sigma Black Belt Certification (in progress) • Certified Technical and Quality Auditor |
Fields of Expertise
continuous quality improvement, analytical data quality assurance, food industry total quality management, ISO 9000 quality system documentation, six sigma quality, FDA 21CFR 11 compliance, aseptic pharmaceutical process validation, computer-system validation, Food and Drug Administration validation, contamination control, sanitary engineering, statistical process control, sanitation standard