Leadership of quality assurance, regulatory compliance, and quality control functions across our global operations. My role ensures that all products and services meet stringent quality standards and comply with regulatory requirements, maintaining our commitment to excellence and integrity.

Provide cross functional quality systems leadership, oversight, and strategic guidance to drive quality initiates and continuous improvements. Serve as a liaison for implementing newly acquired companies through mergers and aquisitions into the quality management system. With the responsibilities below:Lead entire Quality and Regulatory Organization across a multitude of sites globally with ISO 13485 and ISO 9001 registrations.Lead product transitions from MDD/IVDD to IVD/IVDR and ensure compliance to country specific regulations.Champion continuous process improvements through CAPA initiates and harmonization across sites.Oversite and execution of all quality system elements: CAPA, NC, Complaints, Audits, Document Control, Calibration Management, Change Management, Deviations, Supplier Management, etc.Mentor and coach Quality and Operations team members.Implemented and maintain umbrella quality system approach for existing and newly acquired businesses.Support and implement new product development and product changes.

Sharing my home, which is a live, work, present space with my community to ensure cultural appreciation of art and music. "Where the line between the band and the audience ceases to exist. Jersey City's intimate home for jazz, art, and culture."• Setting and executing the overall operations and resources (physical and financial) of the organization.• Coordinator for ADA compliance and safety management.• Communications and marketing strategy which includes social media. • Event coordinator in partnership with the Artistic Director.

Longtime volunteer, turned board member of Riverview Jazz a Jersey City-based 501(c)(3) non-profit organization whose primary mission is to connect a diverse local/regional audience to the incredible music in the greater NYC metropolitan area. Working closely with community organizations, businesses, government, and talent, Riverview Jazz is able to bring a wide range of world-class performances to the people in their respective community.

Ensure Quality and Regulatory compliance through implementation and maintenance of robust electronic quality systems and processes.Direct leadership and responsibility for the electronic quality systems ( training, documentation management, nonconformance, CAPA, and complaints) within three sub departments, Customer Complaints, Document Control, and Quality Systems.

Quality Assurance role responsible for management of the overall quality operations and quality control functions in support of on-site production, design and development, operations, and regulatory compliance, such as:• Review/approve quality control records for completeness, accuracy and acceptability of results.• Manage the NCMR (MRB) and Deviation systems including follow up actions, trending and metrics.• Designs QC experiments, completes investigations, root cause analyses, and reports for out-of-specification results, deviations, CAPAs and other non-conformances as required.• Manage the QA review and approval of incoming material, labeling, line opening/closing, in-process and finished device history records, including BASIS release and ERP transactions.• Review QA/QC Laboratory activities and testing for conformance to written specifications, SOPs, cGMPs, FDA regulations and ISO standards.• Complete timely review of device history records for completeness and for conformance of product to specifications.• Plan department schedules according to company's production requirements.• Write and revises standard operating procedures (SOPs), forms, and flow charts.• Prepare required protocols and procedures for new products, stability studies, validation, or corrective actions.• Manages the Product Stability Program including protocols and reports, scheduling and execution of testing, and investigation of OOS. Responsible for obtaining and storing stability samples.

• Global Complaint Handling coordination of multiple complex/systems-based investigations • Counsels team member in business, company structure, technical and challenging situations• Provides leadership in Virology and Blood Screening Life Cycles, local or cross-site. • Leads and contributes to additional strategic projects in parallel to team activities• Manages critical interfaces, internal and external (e.g. BAs, OEM, Authorities)• Assists leadership team in department strategy • Rotation within Global Regulatory Affairs supporting Centralized and Point of Care Solutions within Serum Work Area High/Mid Volume Systems supporting IVDD transition to IVDR.

• Assume full accountability and resolution of complaint cases in the Virology Life Cycle, which includes planning and execution of complex investigations, ensures completion of complaint Corrective and Preventative Actions.• Mentor and coach new and developing employees within my team.• Provides guidance on correct complaint processing, documentation and for complex investigations being performed by other members of my team.• Maintain compliance in all business activities, including case documentation and training. • Evaluate and investigate complaint cases with very high degree of complexity, e.g. having multiple causes or implications on more than one product. • Represents department in product-related meetings. • Participates and leads global projects to ensure business continuity, process improvements, and employee morale.• Build and maintain relationships with key interfaces.

Global customer support complaint handling and training for RMS virology products.

Troubleshoot and support operations for the RMS Branchburg and Rotkreuz facilities. Troubleshooting includes instrumentation and software performance. Operations support is provided for release and stability of diagnostic reagents manufactured at our RMS facilities. Other activities involve equipment management, equipment repair and maintenance.