Open To Work
OSVALDO CACERES
Toa Baja
Summary
Detail-oriented Quality & Regulatory Compliance Associate with extensive experience in GxP compliance, inspection readiness, and global regulatory affairs. Demonstrated success in batch release, CAPA, contamination control, and quality risk management. Led multiple inspections, including FDA, EMA,PMDA , while implementing site-wide quality systems to ensure market readiness. Strong communication skills in English and Spanish, with a proven ability to drive operational excellence and build influential relationships in the healthcare and pharmaceutical sectors.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Principal Associate QA Compliance, Senior QA Representative-Manufacturing, QA for QCL
Eli Lilly and Company
Carolina
08.2003 - 12.2025
- Spearheaded inspection readiness and acted as primary liaison for global regulatory audits, including FDA and EMA.
- Led self-audits and implemented contamination control protocols across the facility.
- Standardized documentation processes to enhance compliance and operational efficiency.
- Advised on site registration and licensing requirements across jurisdictions, facilitating regulatory submissions and divestiture of legacy products.
- Developed compliance strategies aligned with key business objectives, enhancing regulatory alignment and operational performance.
- Employee of the Year – 2016 for outstanding Site’s contributions.
- Acted as SME for QA, CAPA management, and root cause analysis with respective monthly and quarterly metrics. Final Assessment.
- Led quality agreements program, implemented ship-under-quarantine protocols, and ensured compliance across operations.
- Developing/Implementing Controlled Substance program across Lilly sites. Controlled Substance Officer (CSO)
- Investigations of counterfeited/ fraudulent products. Analytical Chemist with 10+ experience in Lab processes and Equipment (wet chemistry)
- Oversaw batch release for all global markets, ensuring adherence to local regulations.
Education
Bachelor’s Degree - Chemistry
Iowa State University
Ames, IASkills
- Quality and Compliance management
- Good Manufacturing Practices
- Quality management systems
- Regulatory audit readiness
- Deviation and non-conformance investigations
- Corrective and preventive actions (CAPAs)
- Contamination control evaluations
- Change control management
- Product and patient complaint management, investigations, conclusions, and approvals
- Fraud/Counterfeit/Tampering investigations and approvals
- Global customer service (phone or in-person)
- Data analysis and assessment
- Data integrity management
- Data entry accuracy
- Analytical chemistry expertise
- Manufacturing operations oversight
- Regulatory affairs and risk management
- Regulatory submissions and site registration
- Site/Product Licensing and registration compliance
- International regulatory compliance
- Supplier and vendor audits
- Quality agreement negotiations and approvals
- Risk-based quality assurance
- Product divestitures
- New product launches
- FDA regulatory notifications (FAR)
- Change Control executer, reviewer, and approver
- Annual product reviews
- Quality risk management evaluations and approvals
- Root cause analysis and effectiveness verification
- Training compliance education
- Training in DEA regulations
- Train-the-trainer certification
- Performance metrics and improvement
- Operational excellence and audits
- Technical Writing
- Microsoft Office Suite
- TrackWise Power User
- SAP/HANA Power User
- Veeva Vault Poser User
- Regulatory information management (RIM) Power User
- LIMS Power User
Websites
Certification
- Certified Quality Auditor – American Society for Quality
- SixSigma Green Belt
- Supplier-Certified Auditor Train-the-Trainer Certification
Core Skills
Good Manufacturing Practices (GMP), Quality Management Systems (QMS), Regulatory Audit Readiness, Deviation & Non-Conformance Investigations, CAPA (Corrective & Preventive Actions), Contamination Control Evaluations, Change Control Management, Product/Patient complaints management with excellent negotiation skills, Data Analysis/Assessments, Data Integrity, Data Entry, Led Deviations, Change, and Complaints Review Boards, Analytical Chemist for the testing of Raw Materials, Finished Products, and Stability Studies, Oversight of Manufacturing Operations from a Quality standpoint, Regulatory Submissions, Site Registration, Licensing, International Regulatory Compliance, Supplier & Vendor Audits, Quality Agreement Negotiations & Risk-Based Quality Assurance processes, Product Divestitures, New Product launches, FDA notifications (Field Alert Reports, MedWatch), Annual Product Reviews, Annual Reviews, SMRs, CR’s, Self-Audits, Quality Risk Management Evaluations, Root Cause Analysis, Effectiveness Verification, Training Compliance Education, Train-the-Trainer Certified, Performance Metrics, Continuous Improvement, Microsoft Office Suite, TrackWise, SAP, Veeva Vault, RIM (Regulatory Information Management), Darwin (LIMS) and their respective implementations in several sites, Power User/Administrator in several platforms
Languages
Spanish
Native
Native
English
Proficient (C2)
C2
Accomplishments
Employee of the Year 2016 - Exceeded all site metrics, professionalism, living the brand, and served as a role model for over 400 Lilly employees at the Carolina site.
Affiliations
Teaching and tutoring math and science for disadvantaged students from public schools.
Work Preference
Job Search Status
Open to workWork Type
Full TimePart TimeContract WorkSalary Range
$50000/yr - $200000/yrTimeline
Principal Associate QA Compliance, Senior QA Representative-Manufacturing, QA for QCL
Eli Lilly and Company
08.2003 - 12.2025
Bachelor’s Degree - Chemistry
Iowa State University