Roberta Dodson

· Maintaining PCO quality management system (QMS) related documents (including SOPs, policies, guidelines, work instructions, software validation procedures, etc.)

· Establishing quality assurance procedures to ensure quality operations as it pertains to Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR), Good Clinical Practice (GCP) and 21CFR Part 11

· Conducting internal audits to identify and investigate deviations and non-conformances for PCO and other areas of the business as needed.

· Implementing corrective action and preventative action (CAPA) and nonconformance tools as needed for PCO staff, clients and suppliers.

· Developing tools to improve quality assurance practices across Lumanity, as applicable.

· Hosting and management of external audits

· Training and engaging staff to ensure quality standards are met, including training on relevant Standard Operating Procedures (SOPs) and processes related to quality assurance.

· Maintaining training records as required by the Quality Management System (QMS).

· Providing guidance and answering compliance-related queries across Lumanity.

· Building and maintaining relationships with internal stakeholders (e.g., Data Protection Officer, Legal, Cyber Security).

· Collaborates with IT to establish evidence as needed for software validation.

· Overseeing the supplier due diligence and qualification process, including providing qualification review and/or training staff to provide review.

· Overseeing the supplier key performance (KPI) indicator process.

· Overseeing the data destruction process, including updating the process as required to conform to requirements of additional geographies.

· Overseeing PCO staff training pursuant to the PCO Training Matrix.

· Provides oversight and guidance to ensure data across all PCO research studies are maintained in compliance with local requirements and regulations (e.g., GDPR).

· Providing management with Quarterly PCO Quality Corrective and Preventive Action (CAPA) Reports.

· Support central compliance initiatives, including internal audits, special projects

Achievements: Successfully hosted external audits with zero Major findings. Supplied deliverables governed by Standard Operating procedures. Continuously met quarterly goals. Nominated for Lumanity Leadership Program

· Perform quality assurance reviews of standard operating procedures (SOPs), forms and provide recommended updates as needed

· Maintain quality management systems related documents

· Establish quality assurance procedures to ensure compliance to HIPA, GDPR, GCP and 21 CFR Part 11, Title 21 CFR 312, 314

· Conduct internal audits

· Implement corrective actions and preventive actions (CAPA) as needed

· Host external audits

· Maintain oversight of the Quality Management System for Lumanity, Patient Centered Outcomes

Achievements: Reduced Major external audit findings by 50% in year one. Auditee for the ISO 27001 Scope Expansion audit (May 2024) to include VAO to Lumanity certification. Certificate received.

· Organized initiatives, drafted documentation and enforced compliance with best practices

· Built and strengthened relationships with regulatory representatives, vendors and company customers

· Conducted/hosted internal and external audits according to established FDA and ISO compliant procedures

· Supported strategic development and objective setting by analyzing audit outcomes and generating actionable recommendations that were adopted and incorporated into the Quality Management System

· Oversight of full audit lifecycle according to organizational protocol, generating progress and closing reports for leadership and clients

Achievements: Selected participant 2022 Emerging Leaders Cohort, Women at Tempus Mentor (3 mentees), Panelist Tempus 2022 Women at Tempus and Tech Organization Mentorship Event, Achieved GCP Auditor Certification

· Management of day-to-day processing of complaints in scope of 21 CFR 820 and ISO 13485:2016 - 5 direct reports. Interim Safety and Regulatory Reporting Manager-6 direct reports

· Cross functional activities to ensure compliance to Standard Operating Procedures (Complaint Intake, Field Service, Engineering, Regulatory Affairs, Data Analytics, Medical Device Safety, Pharmacovigilance and Regulatory Reporting

· Process implementation for handling of Original Equipment Manufacturer (OEM) events

Achievement: Reduced aging complaints by driving records to closure

● Planned and conducted internal audits of the Quality Management System (QMS)

● Sought opportunities for professional development and training to achieve Lead Auditor certification

● Produced official reports of findings to meet regulatory standards and assist senior leadership with improving operations.

● Established Quality Improvement Plan for Quality Management System (QMS) to drive improvement of the QMS

● Established Standard Operating Procedures- Supplier Audits, Medical Device Change Control

● Successfully planned and hosted Qualification Audits leading to Business Growth and Development

Achievement: Promoted within 6 months of hire

● Associate Director and Manager level decision making

● Assistant Management of Complaint Coordinator/Intake team

● Facilitation of process improvement for complaint handling, intake, MDR and MEDDEV reportability decisions to ensure compliance with regulations

● Revision of Reporting Guidance Document (RGD) per EU MDR requirements

● Collaboration with Senior Quality Engineers for continuous process improvement and complaint closure timeliness

Effectively closed CAPA to mitigate late Medical Device Reports (MDRs)

Achievement: Recipient of Impact Award –August 2019, September 2019

● Quality Management/Quality Assurance Site Lead level responsibilities, as assigned

● Quality Procedure writing /updating to reflect ISO 13485:2016 requirements – Procurement and Vendor Management Procedure, Customer Support Procedure, Post Market Safety Lifecycle

● Implementation of process improvements based on nonconformance identified in quality records and quality procedures to comply with applicable regulations and standards (FDA, ISO 13485:2016 and IEC 62304)

● Retrospective Review of 1015 complaint files in response to FDA 483 Observation and individual writing, coding and submitting of 400 plus MDRs

● Interpretation and Retrospective review of previously written Engineering evaluations and peer review and approval of team reporting decisions