Martha Fiore

About Martha Fiore

Hello my name is Martha M. Fiore, throughout my career in Quality and Compliance I have enforced process improvement programs and implemented effective strategies to optimize operational effectiveness, fulfill client’s requirements, and accomplish organization’s set objectives. I have conducted and coordinated assessments to ensure compliance with company’s defined standards and procedures. I’m an expert in reviewing and approving workload, resolving impending issues, executing root cause and impact analysis, and applying preventive measures. I’m skilled in developing ERP system, policies, and procedures. My expertise lies in ensuring full corporate awareness, understanding, and compliance with all pertinent laws and regulations. From developing and implementing key policies and driving operational compliance to facilitating compliance audits and overseeing high-performing teams. As a results-oriented individual with additional experience in safety and risk management—I welcome our connection!

Experience

1. Manager of Compliance and Regulatory Affairs

   Reed-Lane

   Jan 2024 — Present · Wayne, NJ, US

   Management of Quality Assurance, Compliance, and Validation in conjunction with 21 CFR Parts 210 & 211, Part 11, and Good Manufacturing Practices. Assure operational and quality systems are appropriately documented and function in compliance with all regulatory requirements and internal SOPs. Lead internal and external audits and provide representation and communication during regulatory audits and site visits. Manage all required State and Federal Registrations and DEA requirements. Oversee the review and approval of Master Batch Records, SOPs, APR’s, Risk Assessments, Investigations, Deviations, Complaints, and Validation Protocols and Reports.

Education

• Montclair State University

  Bachelor of Arts in Psychology

Skills

• Gmp
• English
• Outlook
• Microsoft Office
• Html
• Cross-Functional Team Leadership
• Standard Operating Procedure (Sop)
• Microsoft Word
• Powerpoint
• Microsoft Excel
• Quality Assurance
• Process Improvement
• Pharmaceutical Industry
• Business Process Improvement
• Windows
• Leadership