§ GxP Needs Assessment, Audits, and Inspection Readiness (BIMO, GCP, GLP, GDP, GMP)
§ Regulatory Affairs (Regulatory Strategy, Regulatory Submissions)
§ Quality Assurance and Clinical Operations Support
§ Equipment Commissioning, Qualification, and Validation
§ Risk-based, product and phase-appropriate Quality Management System (QMS) design
§ Supplier Qualification and Supplier Quality Management
§ GxP Technology Implementations and eQMS solutions, including Veeva and Master Control
§ FDA and EU-compliant paper, paperless or hybrid document and record management systems
§ Data Integrity, GxP Technology, Computerized Systems Validation (CSV)
§ GxP Training Strategy and Technology – LMS needs assessment, selection, content creation, Instructor-Led, and eLearning
§ Coaching and Professional Development of Quality and Compliance Staff
§ Quality Manual Consulting, Policy, and SOP Writing that leverages information mapping and industry-specific best practices

Head of Quality and Regulatory Compliance for the parent company and acting head of quality for multiple subsidiaries (VANTS). Supported seven (7) investigational products (biologics and small molecule) in early, mid, and late phases of development, including GCP compliance for global clinical trials leveraging multiple CROs and CMOs.
Select Accomplishments:
• Established a risk-based, Sponsor Appropriate Pharmaceutical QMS for all VANTs, SOPs, Templates and Tools
• Study Quality Issue Reviews and CAPA Program Oversight
• Audit CROs, document TOROs, and Quality Agreements
• Perform Supplier Qualification Evaluations and Audits
• Implemented and Validated Veeva (QMS, RIM, eTMF, EDC, and CTMS) and 21 CFR Part 11 Module for DocuSign
• Remediated CRO and CMO partnership inadequacies, including correcting missed requirements, proper audits, and supplier qualification not being followed.

++++See Resume for More Details++++

Led the team responsible for post-market activities for class II medical devices manufactured and marketed under the 3M-Acelity brand. Also, led the implementation of transformation plans, business processes, and technology changes to ensure regulatory compliance, improve the patient and employee experience, reduce risk, and manage overall costs.
• Administration of the Audit and Inspection Readiness Program
• Tracking and trending of KPIs and product complaint data for improvement opportunity identification and root cause analysis
• Regulatory compliance training management, content development, and delivery (eLearning and in-person)
• Oracle Argus Software Implementation and Validation - GVP compliance, complaint handling, and reporting
• Redesigned the compliance audit processes to leverage technology, reducing the administrative burden and risk of human error. Processing time was reduced by 40%, and overall process cost was reduced by 50%.

Leveraged people, processes, and technology to ensure compliance with state and federal requirements. Responsible for risk identification (audit), mitigation, and improvement strategy for Aetna Business Units.
§ Establish and maintain relationships with regulatory information and technology vendors for process management, RSA Archer GRC, Wolters Kluwer, Lexis Nexus, and CEB (Gartner).
§ Oversee budgets, projects, and system implementations.
§ Led and managed compliance issue mitigation projects and corrective action activities in collaboration with Aetna senior leaders (C-Suite), State and Federal Regulators, and DOI authorities.
§ Ensure realization and sustained business value and ROI for implemented technology solutions, transformational change efforts, and inspection readiness for compliance audits.

§ Leader of the corporate process improvement team for two acute care hospitals with surgical centers responsible for managing and facilitating collaborative work done by facility teams to identify and implement solutions to improve safety, clinical quality, compliance, containing cost, increasing revenue, and optimizing patient care. Managed and led kaizen events and staff training on continuous improvement and leveraging Lean Six Sigma in Healthcare.

§ Responsible for leading strategic change, process improvements, technology deployments, and other initiatives to improve quality, cost, experience, and speed of delivery.
§ Ensure fact-based, data-supported opportunity identification and solution design using lean principles, prove business value and ROI, implement support, and lead various corporate transformational change efforts.

§ Perform processes required under the PDL Quality Management System, including but not limited to procedures for Document and Records Management, Deviations, CAPA, Change Control, Complaints, Internal/External Audits, Supplier Quality Management, Adverse Events and Recalls, GxP Training and Qualification, Management Review, APR, and Process Validation.