Associate Director Quality Systems and Compliance

Strategic Quality Leadership – Proven experience in leading and optimizing QMS for medical devices, ensuring compliance and continuous improvement.

Regulatory & Risk Management Expert – In-depth knowledge of risk-based approaches, CAPA, auditing, and regulatory frameworks for global market access.

Process Optimization & Digitalization – Strong focus on datadriven decision-making, ERP implementation, and digital transformation in quality processes.

Hands-on Project & Supplier Management – Extensive experience in supplier qualification, cross-functional project leadership, and stakeholder collaboration.

Responsible for working collaboratively across the Cell Therapy organization to provide strategic GxP compliance support to assure adherence to global health authority requirements across the product lifecycle

Developed and executed strategic vision for the Compliance and Quality Management System including implementation of metrics standards, reducing manual processes and improving regulatory compliance

Facilitate and oversaw responses to GCP and GMP audit and inspections. Support internal and external audit and inspection readiness and preparation. Data Integrity SME and corporate auditor

Site compliance lead and managed internal and external audit activities inclusive of audit training, preparation activities, execution of audit, and audit responses

Ensured compliance with internal and external regulatory agencies and standards (MDSAP and ISO13485) by interpreting and implementing applicable regulations as they apply to products, processes, and procedures

Managed Training Team with responsibilities over LMS implementation and overall site training process

Managed site’s Controlled Substance, Compliance, Quality Systems, and Data Integrity teams

Site lead for Health Authority Inspections and Internal Audit Program with responsibilities including site audit readiness, training, scheduling, and all inspection activities including responses and communications

DEA Compliance responsibilities included annual registration renewals, procurement quotas, year-end inventories, AROCS reporting and suspicious ordering monitoring

Responsible for site global escalation process of critical events and working with cross functional global team determining potential Health Authority escalation. Roles include escalation report writing, Field Alert Report submissions and involvement with market actions

Responsible for development and execution of yearly site Quality and Data Integrity plans

Review and approval of all DEA, Data Integrity, Compliance and Inspection related deviations, CAPA’s, and Change Controls

Provided quality oversight of multiple Live Virus Vaccines and responsibilities for reviewing and QA approval of: Change Requests, Quality Notifications, CAPAs, Validation protocols/final reports, OOS Investigations, SOPs and IQ/OQ/PQ documents

Responsible for reviewing and approving process changes and improvements related to filling of multiple vaccines, and overseeing implementation to identify quality impact. Provided support to manufacturing team to review data trends to identify process improvements. Led quality systems team for tracking/implementing CAPAs and Quality Notification metrics and implementing site wide improvement projects

Supported site internal and external inspections in multiple roles such as: facilitator, note taker, mock inspector and difficult discussion topic preparation

Responsible for the safe operation of production operating area and supervised twelve operators

Overall accountabilities include product quality, asset utilization, schedule attainment and cost associated with operating areas. Worked with supply chain to forecast product mix and schedule plant production runs

Implemented process and product quality improvements for manufacturer of water-soluble food and pharmaceutical grade polymers, applying process techniques to meet customer requirements

Facilitated collaboration among all plants in U.S., Europe, and Asia, sharing ideas across locations to glean best manufacturing practices from each facility and apply them globally to drive cost savings