Regulatory Affairs Quality Assurance
Resume:
Lori A. LaPointe
Quality & Regulatory Affairs Specialist
A dedicated, enthusiastic and self-motivated Regulatory Affairs professional with over twenty years of success in leadership roles, training, developing processes and continuous improvement strategies that build a strong organizational infrastructure. Well-versed in managing cross-functional teams, building relationships with key stakeholders and communicating information in a clear and concise manner. Seeking a challenging opportunity to work enthusiastically independently/with a team to achieve organizational goals.
AREAS OF EXPERTISE
Strategic Planning Risk Assessment Team Leadership Interpersonal Skills Project Management
Process Improvement Communications Training Programs Regulatory Compliance Organizational Development
Results-Oriented Quality Assurance Technical Skills Workflow Development Documentation Management
PROFESSIONAL EXPERIENCE
Quality & Regulatory Affairs Specialist INFOR Greenville, South Carolina 2021-2023
Infor is a global leader in business cloud software products for companies in industry-specific markets. Responsible for managing vendor relationships and ensuring accessibility compliance, reducing costs and improving workflows.
Vendor Management:
Reviewed and evaluated due diligence data, risk assessment and ongoing vendor monitoring requirements to ensure the delivery of high-quality essential services.
Additional responsibilities included generating and monitoring requisitions, overseeing purchase orders, and approving invoices to ensure compliance with the detailed payment schedule in the Statement of Work. Documented, scheduled and communicated audit dates and available resources to relevant stakeholders.
Accessibility:
Subject Matter Expert providing guidance to ensure compliance with Section 508, American Disability Act (ADA) and Web Content Accessibility Guidelines (WCAG).
Served as the internal liaison connecting INFOR with a third-party accessibility vendor and navigated the Voluntary Product Accessibility Template (VPAT) process. Assumed responsibility for fostering accessibility awareness organization wide.
Implemented optimal workflow processes and methods by eliminating costly product-specific agreements as budget constraints prevented additional support for authoring VPATs.
Key Contributions:
Facilitated vendor-stakeholder communication, driving strategy and cost-saving agreements that saved $601K in 2022.
Improved vendor relationships, streamlined payments, and resolved issues, resulting in enhanced collaboration and efficiency.
Secured a three-year enterprise agreement, including discounted audit costs, advisor support, and $290K in cost savings, with increased participation from 3 to 12 products.
Collaborated with Product Managers to train on accessibility compliance and its sales potential, leading to a 90% increase in participation.
Family Caregiver 2018-2021
During this period, I took on the role of a primary caregiver to support ill family members. Responsibilities included providing emotional and physical care, managing medical appointments and coordinating necessary arrangements.
Compliance & Governance Analyst INFOR Greenville, South Carolina 2015 - 2018
Planned and executed internal/customer audits for multiple products, regulations and standards; assisted the Sales and Cloud Hub Teams by supplying answers to compliance questions on hundreds of Requests for Information/Requests for Proposal annually.
Worked with the following regulations/standards to complete these tasks: GAMP 5, ISO 9001, 13485 and 27001, FedRAMP, HIPAA, Payment Card Industry Data Security Standard (PCI), and others as required.
Team Lead for Infor’s Corrective and Preventative Actions (CAPA) process, Int. Traffic in Arms Reg. (ITAR), SSAE 18 Reporting Standard, Section 508 compliance and customer validation assistance.
Annually review and revise policies and procedures, as necessary, to ensure continual improvement of the quality management system.
Key Contributions:
MasterControl: spearheaded the Compliance Team's training initiatives on the implementation of an automated Electronic Quality Mgmt. Software System (eQMS) facilitating seamless communication and ensuring regulatory and ISO compliance.
Sumo Logic Reports: oversaw and documented daily security operations for ITAR customers, submitting relevant reports to the Cloud Team for investigations as needed.
GovCloud Clearance Access Requests: accountable for verifying all access, providing training, ensuring completion and verification, obtaining required approvals before final approval and subsequently monitoring all access types for individual users.
Director of Quality Assurance GLYTEC Greenville, South Carolina 2011 – 2015
Glytec is an insulin management software company for healthcare providers. Responsible for the development and implementation of a comprehensive quality management system, ensuring compliance with internal and external requirements to drive continuous improvement.
Led the development of a comprehensive quality manual including procedures for continuous improvement, analysis and training.
Directed the quality assurance activities of the organization while overseeing the Quality Assurance department, ensuring compliance with internal and external requirements, including legal (e.g. HIPAA), ISO 13485, and 21 CFR Part 820.
Directed the CAPA process along with customer complaint trending, internal and external audits, and Management Review meetings to identify areas of improvement and the effectiveness of the quality management system; drove reduction of recorded complaints down by 70%.
Analyzed and drafted quality system improvement plans to ensure continuous improvement, reduce costs and software-related issues where applicable; reviewed and approved all engineering change orders relating to the quality management system.
Quality Assurance Officer GLYTEC Greenville, South Carolina 2008 – 2011
Established a company-wide quality management system focused on process development and delivery of quality through the development of training sessions for all levels of personnel.
Delivered ISO 13485 company certification under budget and ahead of target, responsible for overseeing all documentation required by ISO 13485 and 21 CFR Part 820.; passed required annual company certifications with no major or minor compliance issues.
Annually reviewed and revised standard operating procedures to ensure effectiveness as necessary.
Managed the Quality Assurance and Human Resources departments temporarily at the CEO’s request; priority was ensuring all employees were covered by health benefits and the employee portion of insurance costs were properly deducted.
Director of Human Resources GLYTEC Greenville, South Carolina 2006 – 2008
Directed the HR strategy in the promotion of organizational development and growth. Handled staffing, onboarding, training, and policy design and implementation. Focused on employee relations and morale, compensation and benefits administration, safety, and welfare. Maintained compliance with OSHA regulations, labor, local and state laws.
Corporate Officer, Executive Coordinator & Investor Relations GLYTEC Greenville, South Carolina 2006 – 2008
Represented the organization at Board of Directors and Shareholder meetings, recording votes and minutes to ensure clear communication. Maintained records of all subscription agreements and investor contact information. Collected, recorded and deposited all funds and issued stock certificates. Reviewed and signed all company checks.
EDUCATION & CERTIFICATIONS
A.S., Associate of Science in Travel and Tourism, Herkimer Community College, Herkimer, NY
Certified ISO13485 Lead Auditor, BSI Group
AWARDS
Exceeding the Teamwork Grade Award, TransWestern Publishing, Inc.
Outstanding Service Award – Shared Decision-Making Team, Elmer Avenue School
Vice President Parent/Teacher Organization, Elmer Avenue School
Editor’s Choice Award for Outstanding Achievement in Poetry, The National Library of Poetry
COMMUNITY INVOLVEMENT & VOLUNTEERING EXPERIENCE
Gilder Creek Farm Welcome Committee Member & Social Committee Chair Simpsonville, SC 2016 – present
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