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OMOTAYO ODIWO
Omaha,NE
Work Preference
Summary
15+ years leading global quality control and GMP compliance in sterile processing and injectable labs and manufacturing environments, including an extensive tenure with leading pharmaceutical company, Pfizer. Leads teams to ensure quality, data accuracy, safety, and efficiency in production and operations. Highly skilled in developing and implementing quality management system and policies. Oversee quality assurance and control processes across operations. Conduct regular audit and assessment to ensure compliance with standards. Collaborate with cross-functional teams to drive continuous improvement initiatives. Analyzing of date and metrics to identify trends and areas for enhancement. Train and mentor staff on quality standards and best practices.
Overview
26
26
years of professional experience
Work History
Associate Director of Quality
Lloyd, Inc.
Shenandoah, IA
08.2017 - Current
- Oversee quality assurance and control across operations. Instrument maintenance, SOP implementation, GMP process compliance, product regulations, and staff training.
- Manage a $2M+ operational budget and lead and mentor a team of 21 direct reports including a Quality Control Manager, a Procurement Manager, Chemists, and Lab Technicians
- Report to CEO, collaborate with Controller, and work cross-functionally across divisions (HR, QA, CMC, Regulatory, Marketing, Supply Chain, Purchasing) on compliance, hiring, operations, and scientific strategies
- Set, track, and manage quality assurance KPIs and benchmarks such as project timelines, shipping goals, instrument expirations, and GMP compliance
- Advance knowledge of CFR Part 210 and 211 GMP compliance
- Consistently receive 100% compliance on audits related to GMP processes and lab equipment
- Reduced operational costs by identifying inefficiencies and implementing cost-saving measures in various departments; led team development and cross-training program to save $60K+ annually
- Implemented LIMS used by 1,000+ staff to improve quality and achieve a 45%+ increase in lab efficiency
- Advanced knowledge of chemical and physical analyses, instrumentation (HPLC, UPLC, IR, ICP, GC, GC-MS), regulations (ie: GMP, FDA, USP, EP, JP, GLP, ICH, OSHA), exponential mathematics, and statistical methodology
- Manage annual raw materials testing, finished products retesting, and product stability programs
- Contribute to drug submissions for the FDA, communicate with FDA inspectors, and prepare documentation
- Pharmaceutical Lab & GMP Processes.
- Review and Approve batch record. Issuance of certificate of analysis.
- Aseptic and sterilization methods
- Microsoft Office tools
Global Quality Control Team Lead
Pfizer
Kalamazoo, MI
01.2008 - 01.2017
- Oversaw global quality control and GMP processes in a lab testing and producing products distributed across North America, South America, Europe, Australia, and Asia for a leading pharmaceutical company (Pfizer) with an annual revenue $62B+
- Managed, trained, and coached a team of 10 including Lab Analysts and Chemists responsible for testing active ingredient products and meeting project timelines in a sterile injectable manufacturing environment
- Implemented technology system and team training initiative to improve communications and automation
- Tracked and managed performance analytics to ensure quality regulation compliance (ie: FDA, EMA, PMDA, USP, EP, JP, GLP, ICH, USDA, OSHA) and consistently meet lab audit requirements at 100% compliance
- Led investigations on OOS/OOT test results to ensure thorough root cause analysis and documentation
- Accurately assessed and approved technical protocol and reports to support validation, verification, and qualification activities
- Analyzed and tracked data for compliance to specifications, documenting, and investigating nonconformities
- Led teams in method transfer, method validation, instrument qualification, protein extraction, and testing
- Fostered a culture of continuous improvement with innovative idea sharing and resources for development
- Pharmaceutical Lab & GMP Processes
Senior Lab & Quality Control Analyst
Pfizer
Kalamazoo, MI
01.2000 - 01.2008
- Managed the quality, scheduling, product monitoring, utility monitoring, and testing performed by the lab
- Served as a Senior Lab Chemist and Pharmaceutical Analyst responsible for analyzing raw materials, performing sensory assessments, and assessing finished products
- Successfully initiated test method transfers between labs and vendors by defining, interpreting, and recommending acceptance criteria and ensuring standardization and protocols across international locations
- Formulated and executed effective and efficient analytical instrumentation protocols for lab equipment
- Oversaw the performance of quality control sampling and testing including drug products, APIs, in-process, and finished products
- Supported the implementation of a Pharmaceutical Quality System (PQS) across all lab operations
- Conducted biological, chemical, and physical tests and analysis including pH, specific gravity, melting point, IR, refractive index, GC-MS, chromatography, flashpoint, ICP, endotoxic, and sterility testing
- Updated and preserved accurate evaluation and reporting of data generated in the lab
Education
Bachelor of Science (B.S.) - Chemistry
Oglethorpe University
Atlanta, GASkills
- Team Leadership & Management
- Strategic Planning, KPIs & Benchmarking
- Data Analytics, Dashboards & Reporting
- Lab Operations & Budget Management
- Pharmaceutical Quality Assurance
- Manufacturing Process & Facility Audits
- SOP Development & Implementation
- Method Validation & Method Transfer
- Gene/Cell Therapy & Microbiology Testing
- Risk Management Programs
- IQ, OQ & PQ Validation Protocols
- Deviations & Batch Disposition
- Global Quality Processes & Management
- Regulatory Submission & Inspection Readiness
- Cost Reduction & Process Improvement
- Recruitment Strategy, Hiring & Training
- Technical & Scientific Communications
- Investigational Medicinal Products (IMPs)
- Quality Management Systems
- Track-Wise, MODA, SAP, LIMS & Workday
- Exponential Math & Statistical Methodology
- OOS, OOT & QA Variance Investigations
- Corrective & Preventative Actions (CAPA)
- GMP Compliance (FDA, EMA, PMDA, USDA & OSHA)
Accomplishments
§ Lead current cost reduction initiative to train teams, install equipment, and bring biological product testing in-house to save a projected amount of $300K+ annually,
§ Reduced operational costs by identifying inefficiencies and implementing cost-saving measures in various departments; led team development and cross-training program to save $60K+ annually
Timeline
Associate Director of Quality
Lloyd, Inc.
08.2017 - Current
Global Quality Control Team Lead
Pfizer
01.2008 - 01.2017
Senior Lab & Quality Control Analyst
Pfizer
01.2000 - 01.2008
Bachelor of Science (B.S.) - Chemistry
Oglethorpe University