GENESIS HARSLEY
Ryder
Hazelwood,MO
1
Certification
10
years of professional experience
Achieved ASQ certifications including CQIA, CQE, CMQ/OE, and CQA, contributing to professional growth.,Implemented food defense strategies and upheld HACCP compliance to safeguard operations.,Drove root cause analysis and CAPA development, resulting in improved operational efficiency.
Work History
SR CORPORATE QA MANAGER - USA & CAN
1 Year 4 Months- Oversee 50+ North American and Canadian accounts across regulated industries, including CPG, cosmetics, food, tobacco and medical devices, leading cross border teams in the U.S. and Canada while driving enterprise wide contractual and procedural compliance, quality strategy, and regulatory alignment with agencies like the FDA and Health Canada.
- Enterprise Quality Strategy – Design and execute a North America–wide QMS framework, aligning operations with FDA, Health Canada, and contractual requirements; ensuring compliance across multiple verticals
- Enterprise Policy Oversight – Direct corporate policy and document governance, ensuring audit readiness across Ryder’s North American network
- Audit & Compliance Leadership – Serve as lead audit liaison with customer, regulatory, and certifying bodies; protecting multimillion dollar accounts
- Leadership & Team Development – Built and guide a cross boarder quality team, fostering professional growth and succession planning while elevating organizational capability
- Regulatory & Contractual Alignment – Strategic liaison with regulators, legal and customers, shaping contractual quality agreements that safeguarded compliance and customer trust
- Cross Functional Influence – Engage stakeholders from frontline associates to Vice Presidents, integrating quality standards into operations, engineering, IT, and customer teams, driving company-wide adoption of quality best practices
- Lean Transformation – Facilitated Value Stream Mapping (VSM) events to identify opportunities for improvement in current state; resulting in a combined total funnel improvement potential of $1.5 Million
- Continuous Improvement Impact – Reduced recurring quality issues by 100%; strengthening customer retention and compliance rating
CORPORATE QA MANAGER
11 Months- Lead the development and oversight of Quality Management Systems (QMS) for diverse Consumer Packaged Goods (CPG) accounts; integrating operations with national and international regulatory, contractual, and procedural requirements
- Strategic QMS Development – Collaborated with executive leadership and senior management teams to develop and implement strategic QMS initiatives, aligning operations with corporate goals and regulatory requirements across North America and Canada
- Regulatory & Licensing – Facilitated medical device registration, manage annual reporting, and oversee ownership transfer processes to sustain compliance during acquisitions and expansions. Provided accurate regulatory information to customers and assist with their quality specifications during startup phases
- Provided leadership on Root Cause Analysis (RCA), Failure Mode Effect Analysis (FMEA) and risk-based decision-making processes to proactively address potential quality issues and mitigate risks
- Executive Collaboration – Supported new accounts by providing regulatory guidance, quality inputs to Request for Proposals (RFPs), Collaborative Due Diligence (CDD), risk assessments (FMEA), authorship of procedures, development of training programs, and deployment of QMS to continuously improve quality
- Enterprise Policy Oversight – SCS Ryder Policy Administrator responsible for managing the Document Control Management System for corporate SOPs, work instructions, and training, ensuring timely updates and compliance
- Contractual Alignment – Reviewed and approved Quality Agreements, ensuring communication of implications to internal stakeholders
- Audit & Compliance Leadership – Supported external audits (2nd and 3rd party), providing audit expertise and ensuring adherence to regulatory standards
QA MANAGER
2 Years 9 Months- Head of Quality, in a startup environment, responsible for the overall development and implementation of the ISO13485 based QMS structure for the BJC HealthCare 3PL distribution center to ensure compliance with contractual, procedural, and regulatory requirements for pharmaceuticals and medical devices
- Regulatory Compliance – Successfully developed and coordinated audit readiness activities; achieving the 3PL Provider License from the MO Board of Pharmacy to distribute drugs and medical devices in Missouri and Illinois; achieving zero major regulatory audit findings in 2 consecutive years
- Cross Functional Leadership – Partnered with operations, engineering, and IT in the site’s WERC certification process, which involved benchmarking against eight (8) key warehousing processes; successfully achieving certification for best-in-class processes; leading to revenue growth and service quality
- Enterprise Strategy – Directed, managed, and executed corporate business strategies and lead strategic business initiatives related to continuous improvement and compliance resulting in significant improvements in compliance, operational efficiency, and customer retention
- Team Leadership – Built and developed a high performing quality organization of 4-10 associates across 3 shifts to inspect, analyze and reporting quality; sustaining 100% retention while elevating compliance culture
- Operational Impact – Established metrics to drive improvements related to corrective and preventive action (CAPA), complaints, audits, and training; reducing CAPA-related findings by 58%, driving operational excellence and maintaining a compliant, audit-ready status across all business units
- QMS Execution – Designed, implemented, and adapted the Management Review Process, leading meetings, overseeing quality metrics, and reporting KPIs to top management for strategic decision-making
- Mentoring & Training – Provided leadership, training, mentoring, and technical expertise to ensure high-quality systems and outputs which supports business needs and ensure compliance and customer satisfaction
- Enterprise Influence – Lead a quality council comprised of 15+ quality managers to standardize QMS processes, driving continuous improvement and alignment with regulatory requirements across diverse regions
- Lean Transformation – Facilitated Value Stream Mapping (VSM) events to identify opportunities for improvement in current state; resulting in a combined total funnel improvement potential of $1.9 Million
QA MANAGER
2 Years- Overall responsibility for the development, implementation and sustainability of the ISO 9001 based Quality Management Systems and regulatory compliance system at the Pfizer McPherson site to ensure the Integrated Facilities Management (IFM) services comply with contractual and procedural requirements
- Conducted and supported both internal and external IFM audits, identified risks and implemented corrective action plans to ensure compliance and prevent regulatory findings; leading to risk mitigation, improved customer satisfaction, or increased business value
- Successfully developed and continues to maintain a robust Quality Management System that has resulted in a 2-year trend of zero regulatory findings
- Conduct the monthly Quality Business Review with the client and the executive leadership team
- Provides to the Operational Business Units and Quality organization consultation and interpretation of regulations/guidelines related to GxPs, as applicable
- Manages relationships with clients and vendors to efficiently provide services that meet or exceed customer expectations
- Collaborated with cross functional teams on investigations, RCAs, and CAPAs associated with non-conformances, complaints, and internal audits
- Proactively performed trend, data and root cause analyses to identify the top causes of GDP errors; resulting in the development and facilitation of GDP training and work aids. This initiative yielded a 9.2% reduction in errors, a 20% improvement of the KPI target, a reduction in regulatory risk and an improvement of internal audit readiness
- Employs statistical tools to analyze data, identify trends and create reports comprised of proactive identification of opportunities for improvements
- Managed, qualified and audited suppliers in accordance with quality agreement
- Provided interim coverage for Director of Quality
OPS QUALITY ENGINEER
3 Years 2 Months- Responsible for collaboration with Operations and Product Quality functions to develop and implement corrective and preventive actions to effectively manage product quality risks and close operational process gaps
- Successfully led and coordinated the V4 QC Sample Reduction kaizen; generating a hard cost savings of $73,500 per year. This kaizen was a critical segment of a larger initiative where over $147,000 of combined hard & soft savings was delivered
- Proactively coordinated and implemented a cost avoidance resulting in an annual savings via repurposing VHP materials
- Achieved American Society for Quality (ASQ) Certified Quality Engineer (CQE)
- Achieved Lean Leader certification
Education
Bachelors - Biology
Skills
STRATEGIC PLANNING & EXECUTION
ORGANIZATIONAL LEADERSHIP
REGULATORY COMPLIANCE
CONTINUOUS IMPROVEMENT
PROJECT MANAGEMENT
Certification
- BSI - ISO 13485:2016 EXEMPLAR GLOBAL LEAD AUDITOR
- ASQ - CERTIFIED MANAGER OF QUALITY/ORGANIZATIONAL EXCELLENCE
- ASQ - CERTIFIED QUALITY IMPROVEMENT ASSOCIATE
- ASQ - CERTIFIED QUALITY ENGINEER
- ASQ - CERTIFIED QUALITY AUDITOR
- AIB- CERTIFIED FOOD DEFENSE COORDINATOR
- AIB- HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP)
- AIB- PREVENTIVE CONTROL QUALIFIED INDIVIDUAL (PCQI)
- CURIUM - LEAN LEADER
Timeline
SR CORPORATE QA MANAGER - USA & CAN
Ryder
04.2025 - CurrentRead More
CORPORATE QA MANAGER
Ryder
05.2024 - 04.2025Read More
QA MANAGER
Ryder
08.2021 - 05.2024Read More
QA MANAGER
Pfizer (Compass Group/Sodexo)
08.2019 - 08.2021Read More
OPS QUALITY ENGINEER
Curium Pharma
07.2016 - 09.2019Read More
Webster University
Bachelors from Biology
Read More