Monica Richmond
Kenosha
Summary
Proven expertise in ensuring compliance with global regulations including REACH, RoHS, PFAS, and US Conflict Minerals. Developed and executed strategies that align with complex legal requirements, enhancing collaboration among procurement, R&D, and regulatory teams. Over 10 years in product stewardship and 12 years in quality systems, dedicated to improving regulatory compliance and advancing environmental sustainability. Focused on delivering practical solutions that meet organizational and industry standards.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Director, Product Stewardship
Abbott Laboratories Limited
North Chicago
08.2020 - 03.2025
- Directed company-wide program ensuring compliance with regulations on chemical control, including global global REACH, RoHS and Stockholm and Minamata Conventions, EU MDR, TSCA, CA Prop 65; circular economy / extended producer responsibility for packaging, batteries, and electronics; and minerals due diligence reporting for US Conflict Minerals.
- Developed strategic goals, and implemented policies and procedures to facilitate adherence to compliance standards.
- Collaborated with procurement, R&D, regulatory, and quality teams to maintain alignment with compliance requirements.
- Presented issues and proposed solutions to senior management for timely decision-making.
- Contributed insights to company's annual sustainability report.
- Created job hierarchies for individual contributors and leaders, mentoring staff for professional growth.
- Secured funding for replacing legacy software supporting the compliance program.
- Managed budget for subscriptions, external services, travel, and training needs.
Manager, Product Stewardship
Abbott Laboratories Limited
Lake Forest
08.2019 - 08.2020
- Responsible for ensuring the division complied with regulations for chemical control, extended producer responsibility, and mineral due diligence reporting.
- Delegated work to staff, setting priorities and goals.
- Managed departmental budget effectively to support compliance initiatives.
- Implemented process improvements and key program metrics that increased operational efficiency.
- Collaborated with procurement, R&D, regulatory, and quality teams to enhance compliance outcomes.
- Presented strategic solutions for compliance issues to senior management, driving informed decision-making.
Principal Specialist Product Stewardship
Abbott Laboratories Limited
North Chicago
05.2015 - 08.2019
- Delivered subject matter expertise in chemical control, extended producer responsibility, and mineral due diligence reporting across corporation.
- Developed and executed strategic goals across divisions for program advancement.
- Identified process improvements to enhance efficiency in key procedures and software systems.
- Managed extended producer responsibility program, ensuring compliance with EU Battery, Packaging, and Electronic waste regulations.
- Coordinated SOW with external service provider to streamline program execution.
- Administered division-level program audits and engaged with teams to implement solutions.
- Conducted software and systems testing to ensure quality and reliability.
Principal Global Quality System Specialist
Abbott Laboratories Limited
Lake Forest
02.2012 - 05.2015
- Managed execution, approval, and served as subject matter expert on nonconforming products and CAPA management.
- Supported internal and external inspections to uphold quality assurance standards.
- Coordinated cross-functional teams to resolve quality issues efficiently.
- Guided teams on regulatory requirements for Quality Systems compliance.
- Conducted root cause investigations using problem-solving techniques like 5 Whys.
Customer Care Professional
Abbott Laboratories Limited
Lake Forest
02.2010 - 02.2012
- Analyzed customer data to support complaints, risk evaluations, and investigations.
- Monitored customer issues regarding instrument and assay performance for timely resolution.
- Collaborated with internal teams to develop strategies that met customer needs and improved product quality.
QA Professional – Division Quality Systems
Abbott Laboratories Limited
North Chi
07.2003 - 02.2010
- Published monthly metrics reports to support management reviews of quality system effectiveness.
- Implemented corporate-wide software solution, developing standardized CAPA metrics across divisions.
- Managed document change control for quality system manual policies, ensuring regulatory compliance.
- Contributed to quality system improvement projects focusing on metrics, CAPA, risk management, and field actions.
R&D Tech II – PRISM Systems Integration
Abbott Laboratories Limited
North Chicago
01.2002 - 07.2003
- Analyzed PRISM software versions, hardware, and assay performance at Abbott Diagnostics.
- Demonstrated PRISM Analyzer operation to external customers, enhancing product satisfaction.
- Collaborated with the team to ensure the seamless integration of the PRISM instrument and assays.
Product Specialist – Cardiac Business Team
Abbott Laboratories Limited
North Chicago
10.1999 - 01.2002
- Developed and tested Anti-Arrhythmic and Cardiac Marker Test kits, enhancing diagnostic accuracy.
- Led Automated Procedure of Antibody Qualifications Project to streamline testing processes.
- Increased overall efficiency in advancing cardiac diagnostics through optimization strategies.
Education
Bachelor of Science - Biological Sciences
University of Wisconsin Parkside
Kenosha, WI12-1998
Skills
- Quality management systems (ISO 13485, 21 CFR 820)
- Process documentation and control
- Corrective and preventive action (CAPA)
- Policy and procedure development
- Process improvement
- Data analysis
- Regulatory compliance
- Chemical control
- Extended producer responsibility
- Circular Economy
- Mineral due diligence
- Sustainability reporting
- Team leadership
- Program and budget management
- Strategic planning and goal setting
- Employee training and mentoring
- Cross-functional collaboration
- Effective communication skills
- Issue resolution
- Software implementation
Certification
- American Society of Quality, Quality Auditor Certification 2009 – 2024
- American Society of Quality, Quality Engineer Certification since 2006 – 2024
References
References available upon request.
Timeline
Director, Product Stewardship
Abbott Laboratories Limited
08.2020 - 03.2025
Manager, Product Stewardship
Abbott Laboratories Limited
08.2019 - 08.2020
Principal Specialist Product Stewardship
Abbott Laboratories Limited
05.2015 - 08.2019
Principal Global Quality System Specialist
Abbott Laboratories Limited
02.2012 - 05.2015
Customer Care Professional
Abbott Laboratories Limited
02.2010 - 02.2012
QA Professional – Division Quality Systems
Abbott Laboratories Limited
07.2003 - 02.2010
R&D Tech II – PRISM Systems Integration
Abbott Laboratories Limited
01.2002 - 07.2003
Product Specialist – Cardiac Business Team
Abbott Laboratories Limited
10.1999 - 01.2002
Bachelor of Science - Biological Sciences
University of Wisconsin Parkside
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