Lori G. Aleshin
Columbia
Summary
Creative, high energy seasoned Quality Professional with demonstrated history of compliance in the cosmetics, OTC, medical devices and pharmaceutical industries (cGXP). Wide range of expertise in sterile aseptic manufacturing. Pharmaceutical product line includes 503B, IV bags, prefilled syringes, oral solid dosage (OSD), inhalation and vials. Diverse background in many aspects of Quality and Regulatory Affairs. Strengths include hosting agency audits (FDA, Notified Bodies, Board of Pharmacy, MDSAP, Health Canada, OSHA), staff building and mentoring, audits, investigations / CAPAs, risk management, change management, as well as continuous improvement programs. Exhibit excellent problem-solving, common sense and conflict resolution skills.
Overview
23
23
years of professional experience
1
1
Certification
Work History
Head of Quality (Executive)
Nephron
07.2023 - 10.2024
- Company Overview: Sterile Compounding Pharmaceuticals
- Served as the Executive Quality Management representative to ensure all pharmaceutical products meet company, consumer, and regulatory expectations of excellence.
- Directly managed VP of Quality, Director of Quality, Pharmacist, Senior Quality Managers and Supervisors and oversaw approximately 150 indirect employees in quality and microbiology.
- Liaised with medical, legal, regulatory, product development and operations teams to ensure compliance with regulatory requirements.
- Quality Management Executive with responsibility for ensuring GMP and an effective QMS.
- Set Quality and Compliance goals and objectives; established metrics to continuously monitor site Quality performance.
- Provided technical direction and leadership to direct the quality review of product documentation, including deviations, investigations, corrective and preventative actions (CAPA) and change controls.
- Represented Quality in site governance and quality management review meetings (QMR) and Quality Shop Floor.
- Shaped and influenced Quality perspective and actions based on regulatory inspections, internal audits and third-party audits.
- Led compliance audits and regulatory inspections by health authorities (e.g., FDA, Health Canada).
- Provided expert interpretation and application of regulatory guidelines to ensure sterile manufacturing operations, facilities, and documentation adhere to regulatory requirements, company procedures, and are consistent with industry standards.
- Sponsored Quality and Compliance harmonization, integration, and continuous improvement initiatives across the site.
- Directed quality oversight of change management, supplier quality, internal audits, complaints, FAR, adverse events and recalls.
- Sterile Compounding Pharmaceuticals
- Hired Director of Contamination Control Strategy (CCS) and oversaw the CCS for the sterile and aseptic manufacturing processes by applying the HACCP methodology.
- Implemented Key Process Indicators (KPI) metrics for Quarterly Quality Management Review (QMR).
- Introduced Right the First Time (RTFT) metric and increased RTFT by 30% by addressing repeat root causes and investigations back log.
- Co-developed Environmental Monitoring Advisory Committee (EAC) to review MODA trending data for the specific processes, cleanrooms and personnel.
- Brought up 8 furloughed 503B production lines; completed all hold time studies, process and cleaning validations.
- Provided direct quality oversight of two new production lines for two control substance products (from R&D to distribution).
- Led several teams in implementing a continuous improvement programs, resulting in approximately 25% increase in compliance efficiency and a reduction in audit findings.
Director of Quality (Corporate North America sites)
Athenex, Inc.
08.2021 - 05.2023
- Company Overview: Pharmaceuticals
- Oversaw the GMP and GXP quality assurance (QA) departments across four (4) sites to ensure all pharmaceutical products meet company, consumer, and regulatory expectations of excellence.
- Directly managed Senior Quality Managers, Engineers and 30 indirect quality control (QC) lab, micro lab, and QA employees.
- Develop and execute quality control / quality assurance (QC / QA) roadmap and resource requirements.
- Liaise with medical, legal, regulatory commercial, pharmacovigilance, and operations teams to ensure compliance by responding to audits, recalls, and field alerts.
- Developed GMP and GXP procedures, systems, and quality teams to standardize 4 sites: sterile injectables (503B), aseptic manufacturing, clinical packaging, and contract manufacturing organization (CMO / CMDO) site.
- Pharmaceuticals
- Led compliance audits and regulatory inspections by health authorities (e.g., FDA, California Board of Pharmacy).
- Developed and maintained Food & Drug Administration (FDA) drug reporting system to track site metrics in alignment with regulatory and site management requirements.
- Drove Quality Review Board (QRB) and Quality Management Review (QMR) to establish roadmap for strategic quality improvements and priorities.
- Improved investigations by providing site wide training and introducing Root Cause Analysis (RCA) tools.
Director of Quality and Regulatory Affairs
Ivoclar Vivadent Inc.
07.2018 - 07.2021
- Company Overview: Medical Devices
- Served as the Corporate Quality Management representative for North American sites to ensure quality management system requirements were efficiently established and maintained.
- Coached and guided employees on regulatory requirements organization wide.
- Directed regulatory- and quality-related activities for laboratory, validation, engineering, and production departments to guarantee compliance with federal regulations, including Medical Device Single Audit Program (MDSAP), FDA, Environmental Protection Agency (EPA), Health Canada, Occupational Safety and Health Administration (OSHA), and European Medicines Agency (EMA).
- Managed major overhaul of QMS and electronic training systems for every department.
- Led regulatory inspections by health authorities (e.g. Successfully obtained MDSAP Certification and maintained compliance).
- Collaborated with European (EU) CMO’s parent company in Liechtenstein and global sister corporations to reduce customer complaint time, increasing response time by 30%.
- Decreased complaints by 17% by analyzing trends to understand major issues.
- Seamlessly managed regulatory product registrations, including 510K applications (FDA) and Canadian license applications for product registration process across Japan, Korea, Taiwan, Philippines, Columbia, Mexico, Brazil, and other countries as required.
- Managed and maintained regulatory certifications, including ISO 13485, Medical Devices Directive (MDD), and MDSAP.
- Served as safety manager and data protection officer.
- Created safety manager position and hired within.
- Passed all OSHA audits.
- Developed all procedures and job description for data protection officer responsibilities to align with EU requirements.
- Direct oversight of complaints, adverse events, and post market surveillance (PMS).
- Medical Devices
Executive Director of Quality and Regulatory
Safetec of America, Inc.
02.2014 - 07.2018
- Company Overview: Pharmaceutical OTC & Cosmetics
- As an integral member of executive leadership team, reported directly to Chief Executive Officer (CEO).
- Served as trusted advisor to team to ensure business objectives aligned with customer expectations and operational goals.
- Supervised 40 employees across 3 North American sites.
- Directed all regulatory and quality activities for laboratory, validation, engineering, and production departments to ensure compliance with FDA, EPA, Health Canada, OSHA, and Centers for Disease Control (CDC) regulations.
- Implemented innovative quality systems and rebuilt and designed QMS with a newly hired team of quality employees in the first 2 to 3 years of tenure.
- Increased 3rd party quality audit scores, resulting in Current Good Manufacturing Practices (cGMP) UL Certification.
- Led compliance audits and regulatory inspections by health authorities (e.g., FDA, Health Canada).
- Provided voice to and from customers and vendors, served as liaison, and drove consensus across all technical aspects.
- Facilitated and led training on FDA and regulatory requirement topics for all employees.
- Pharmaceutical OTC & Cosmetics
Quality Engineering and Investigations Manager (QEI)
Hospira, Inc.
05.2001 - 02.2014
- Company Overview: Pharmaceutical & Medical Devices
- Multiple GMP promotions and positions.
- Managed a team of 30 cGMP quality management team members, including quality engineers, quality lab technicians, and quality inspectors across quality engineering auditing, training, and laboratory departments.
- Reported and analyzed quality metrics for quality management review (QMR).
- Directed quality engineering, auditing, corrective and preventive action (CAPA), MRB, and CAPA Review Board (CRB).
- Supported corporate CAPA and investigations for sister companies and suppliers.
- In earlier roles, served as Senior Quality Engineer, Operational Excellence and Project Manager; started with Abbott Laboratories (spun off to Hospira); Acted as Site Quality Manager substitute for nine months in 2012.
- Led supplier quality, manufacturing quality, and incoming quality programs in coordination with global operations, resulting in successful audits.
- Awarded Operational Excellence for major overhaul of Quality and Manufacturing operations using Lean concepts.
- Managed quality engineering, laboratory, quality budget, and provided technical support in conjunction with global operations.
- Supported many Hospira sites within US and global with engineering projects and investigations.
- Oversaw internal and supplier audits, including ISO 9001, ISO 13485, cGMP, and good practice guidelines and regulations.
- Pharmaceutical & Medical Devices
Education
Master of Public Administration Degree - Healthcare Management
Keller Graduate School of Management
Master of Business Administration Degree - Finance
Keller Graduate School of Management
Bachelor of Science Degree - Chemistry with a Minor in Math
Southern Arkansas University
Skills
- Process Development
- Aseptic / Sterile Manufacturing
- Quality Auditing
- Regulatory Compliance
- Quality Management Systems
- Written & Verbal Communication
- Change Management
- Risk Management
- Employee Training & Development
- Root Cause Analysis
- CAPA
- Operational Excellence
- Annex 1
- Policy & Procedure Development
- GxP
- ICH
- 21 CFR
- 210
- 211
- 180
- Continuous Improvement
- Supplier Quality
Certification
- MDSAP Lead Auditor Training, Oriel STAT A MATRIX
- Certified Lean Six Sigma Green Belt / Six Sigma Black Belt, Oriel STAT A MATRIX
- ISO 13485 AND ISO 9001 Certified Lead Auditor, Calisco 2016 / QAI-2004 / UB TCIE
- Project Management (PMP / PMBOK ) 10-Week Course, Canisius Center for Professional Development
Technology Skills
- Microsoft Office Suite (Word, Excel, PowerPoint)
- Microsoft Project
- Minitab
- QMRP
- SAP
- Trackwise
- LIMS
- Master Control
Executive Profile
Creative, high energy seasoned Quality Professional with demonstrated history of compliance in the cosmetics, OTC, medical devices and pharmaceutical industries (cGXP). Wide range of expertise in sterile aseptic manufacturing. Pharmaceutical product line includes 503B, IV bags, prefilled syringes, oral solid dosage (OSD), inhalation and vials. Diverse background in many aspects of Quality and Regulatory Affairs. Strengths include hosting agency audits (FDA, Notified Bodies, Board of Pharmacy, MDSAP, Health Canada, OSHA), staff building and mentoring, audits, investigations / CAPAs, risk management, change management, as well as continuous improvement programs. Exhibit excellent problem-solving, common sense and conflict resolution skills., Process Development, Aseptic / Sterile Manufacturing, Quality Auditing, Regulatory Compliance, Quality Management Systems, Written & Verbal Communication, Change Management, Risk Management, Employee Training & Development, Root Cause Analysis, CAPA, Operational Excellence, Annex 1, Policy & Procedure Development, GxP, ICH, 21 CFR, 210, 211, 180, Continuous Improvement, Supplier Quality
Timeline
Head of Quality (Executive)
Nephron
07.2023 - 10.2024
Director of Quality (Corporate North America sites)
Athenex, Inc.
08.2021 - 05.2023
Director of Quality and Regulatory Affairs
Ivoclar Vivadent Inc.
07.2018 - 07.2021
Executive Director of Quality and Regulatory
Safetec of America, Inc.
02.2014 - 07.2018
Quality Engineering and Investigations Manager (QEI)
Hospira, Inc.
05.2001 - 02.2014
Master of Public Administration Degree - Healthcare Management
Keller Graduate School of Management
Master of Business Administration Degree - Finance
Keller Graduate School of Management
Bachelor of Science Degree - Chemistry with a Minor in Math
Southern Arkansas University