Marcus Gesner
Norton,MA
Summary
Veteran senior regulatory and quality assurance executive with history of lifting performance and achieving compliance for top-tier companies in medical device, and pharmaceutical industry. Hands-on proactive manager with adaptable and creative approaches. Talented coach and mentor with expertise in establishing, regulatory, quality, manufacturing, and supply chain processes resulting in higher productivity, efficacy, and profitability. Excels under intense regulatory scrutiny, resolving issues at speed, while achieving standards of excellence.
Overview
23
23
years of professional experience
1
1
Certification
Work History
Senior Vice President of Customer Quality
Olympus
01.2023 - Current
- Providing global strategic leadership for all postproduction quality processes and operations worldwide
- Defined and implemented global strategy for Recalls & Removals, Distribution, Post Market Surviellence, Complaint Handling, Regulatory Reporting, and Field Service / Repair integrating multiple regions and products into scalable global standards
- Established organization model, hired, and led a global team of 5 Vice Presidents, and overall organization of ~1500 globally
- Successfully implemented strategy for FDA Warning Letter issues, including building success by working with FDA to build remediation and recovery plan
- Responsible for overall Annual Operating Plan of ~$150M
- Led initiative with executive officers to implement a global compliance and patient safety program, including new company core values, quality and compliance objectives, and global program structure.
Vice President of Quality – Global Complaints Management
Olympus
01.2021 - 01.2023
- Providing strategic leadership for all aspects of Complaint Handling, Regulatory reporting, and product trending worldwide
- Driving improvements and compliance to regulatory standards
- Leading remediation activities inheritied compliance issues, including FDA strategies and commumnications
- Retired a 2018 FDA/DOJ plea agreement for MDR reporting and 510k submissions in 2022
- Developed and implemented a global organization model, including competency and capacity building
- Established global program to implement global processes and technology platforms.
Vice President - Supply Chain Quality
Juul Labs
01.2018 - 01.2021
- Driving strategic and tactical leadership for JUUL Labs’ global supply chain, including all aspects of manufacturing, distribution, and vendor management
- Established global processes to achieve production execellence while meeting domestic and international regulortory standards
- Provided leadership for global Employee Health and Safety as well as Global Sustainability programs
- Achieved medical and pharmaceutical production standards and practices while meeting production demands in a fast growth startup environment
- Lead for regulatory strategy, authoring, and submission of Chemistry Manufacturing Controls section of JLI’s Premarket Tobacco Application with FDA.
Principal Consultant – Transformative Quality Assurance
Halloran Consulting
01.2017 - 01.2018
- Providing innovative strategic leadership and expertise to design and help implement efficient compliant processes which release value to our client’s businesses
- Expertise includes; executive level global change leadership, organizational designs ensuring transformational success, Regulatory submissions (510k, PMA, NDA) & compliance remediation, Quality System design & development, Quality process transformation, Sterilization services & processes, global post market regulatory processes, product design & development, and Medical evaluation of fielded product performance.
Vice President Post Market Quality Assurance
Boston Scientific
01.2014 - 01.2017
- Providing strategic leadership to all Post Market Quality operations worldwide, including Complaint Handling, Medical Device Reporting, Field Action/Recalls, Vigilance Reporting, Product Performance Monitoring, Failure Analysis, Project Management, Process Improvement, and Regulatory Communications
- Leading a global 350 person organization in addition to a significant outsourced off shore operation
- Directing an annual budget of $46 million dollars
- Sponsoring global change initiative to implement harmonized Post Market processes, including electronic system, communications, and next generation data analysis and reporting.
Director of Quality and Corporate Sterilization Services
Boston Scientific
01.2013 - 01.2014
- Oversee quality operations and systems for distribution/manufacturing site generating $4.5 billion in revenue and sterilization facility producing $2.5 billion
- Maintain all U.S state licensing for sale of medical devices and drug products
- Direct 2 teams charged with managing outsourced sterilization processes/vendors, such as sterilization validations of Ethylene Oxide, Gamma Radiation, and Electron Beam sterilization
- Recruit, develop, and manage 50-person staff, including 6 direct reports spanning Quincy MA, Coventry RI, Maple Grove MN, and Galway, Ireland
- Maintained USA 510k, CE mark status for European countries, as well as approval status in Canada, Australia / New Zeland, Japan, and Brazil
- Reduced cost and burden by sponsoring program to standardize sterilization process worldwide
- Selected for and completed company's advanced executive leadership development program
- Only 50 employees of 20,000 are chosen each year for this prestigious program.
Director, Global Quality Systems
Boston Scientific
01.2009 - 01.2013
- Responsible for Management Controls, CAPA, Nonconforming Events, Standards Management, External Audit Management, Notified Body Management, and Recalls
- Established and managed global user communities, CAPA Review Boards, standardized metrics reporting, risk-based investigations/resolutions, training programs, and reward/recognition programs for CAPA (Corrective and Preventive Actions) and NCE (Non-Conforming Events) processes
- Delivered effective, efficient external audit management process, including audit readiness program
- Contributed to achievement of zero CAPA-related FDA “483 Observations” in over 3 dozen FDA inspections by leading $7 million program to develop and implement global process/automation for both CAPA and NCE across 20 locations.
Senior Manager, Corporate Post Market Surveillance
Boston Scientific
01.2005 - 01.2009
- Managed and developed team of 4 principal engineers
- Planned, improved, and managed complaint handling process involving 45,000 complaints per year across 20 locations
- Designed and established training programs
- Established and maintained standardized metrics reporting for products and system performance, training programs, and risk-based complaint investigations
- Achieved successful Corporate Warning Letter re-inspections of complaint handling process by establishing universal talk tracks and storyboards
- Developed and implemented electronic submission of MDRs (Medical Device Reports) in collaboration with FDA, facilitating validated data transfer with direct upload to FDA databases
- Increased on-time MDR reporting from 80% to 99.7% by instituting consistent decision-making process, comprehensive operator training, and regular monitoring/measuring of key performance indicators.
Manager, Post Market Surveillance & CAPA
Covidien
01.2004 - 01.2005
- Oversaw divisional processes, which involved managing team of 15 quality analysts responsible for post-market surveillance call center and CAPA for Kendall Healthcare Division comprised of 30 locations
- Improved complaint closure timeliness by 70% and reduced number of in-depth investigations through statistics (use of statistical modeling) by 45%
- Enhanced and maintained corporate-wide electronic CAPA and complaint handling systems spanning 80 company locations.
Corporate Quality Consultant/Corporate Internal Auditor
Covidien
01.2003 - 01.2004
- Performed site audits to evaluate integrity of corporate and manufacturing site quality management systems relative to international regulatory guidelines, standards, regulations, and company policy
- Disseminated best practices and deficiency resolution guidance to manufacturing sites and executive management
- Provided total visibility of existing and emerging issues to business managers spanning all plants and divisions
- Achieved by transforming audit data management from single-event, hard-copy process to automated database to enable data tracking, reporting, trend analysis, and risk-based audit planning
- Decreased cycle time for completion of audit related corrective actions by 50% within 1 year.
Senior Quality Analyst
Covidien
01.2002 - 01.2003
- Triaged customer calls by categorizing calls (inquiries, complaints, and adverse events)
- Created and improved product labeling and training processes
- Visited customers to address clinical matters, deliver product training, and resolve product issues
- Educated co-workers on root cause analysis, human error prevention, and clinical insight for drug/medical device products
- Interacted with customers and sales, R&D, and plant operations staff.
Education
Bachelor of Science - Medical Technology
North Adams State College
North Adams, MAAssociate of Science - Nursing
Bristol Community College
Fall River, MASkills
- Strategic Planning and Leadership
- Operations Leadership
- Quality Systems
- Quality Assurance
- Regulatory Compliance
- Due Diligence Functions
- Organizational Design and Development
- FDA & International Regulators
- Global Change Management
- Corrective Actions & Recalls
- Sterilization Service & Process
- Process Improvement
- Drug Licensing & Distribution
- Regulatory Submissions
- Financial Management
- Operational Excellence
- KPI Tracking
Certification
- Registered Nurse License, Commonwealth of Massachusetts
- Six Sigma Green Belt
- Certified Medical Technologist, American Society of Clinical Pathologists
Timeline
Senior Vice President of Customer Quality
Olympus
01.2023 - Current
Vice President of Quality – Global Complaints Management
Olympus
01.2021 - 01.2023
Vice President - Supply Chain Quality
Juul Labs
01.2018 - 01.2021
Principal Consultant – Transformative Quality Assurance
Halloran Consulting
01.2017 - 01.2018
Vice President Post Market Quality Assurance
Boston Scientific
01.2014 - 01.2017
Director of Quality and Corporate Sterilization Services
Boston Scientific
01.2013 - 01.2014
Director, Global Quality Systems
Boston Scientific
01.2009 - 01.2013
Senior Manager, Corporate Post Market Surveillance
Boston Scientific
01.2005 - 01.2009
Manager, Post Market Surveillance & CAPA
Covidien
01.2004 - 01.2005
Corporate Quality Consultant/Corporate Internal Auditor
Covidien
01.2003 - 01.2004
Senior Quality Analyst
Covidien
01.2002 - 01.2003
Bachelor of Science - Medical Technology
North Adams State College
Associate of Science - Nursing
Bristol Community College
- Registered Nurse License, Commonwealth of Massachusetts
- Six Sigma Green Belt
- Certified Medical Technologist, American Society of Clinical Pathologists
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