Marie Florestal

About Marie Florestal

I am a Quality professional with extensive experience in Quality Systems and compliance management in the pharmaceutical, medical device, consumer healthcare, and biotech industries. I have extensive experience in leading organization in implementing robust processes that identify compliance gaps and developing strategies for sustainable compliance to corporate policies and FDA regulations. I have served as a senior consultant managing, auditing and restructuring companies under consent decree injunctions, FDA-483s, and Warning Letters into GMP-compliant units that met (and exceeded) verification activities. Throughout my career, I have worked with major pharmaceutical, medical device and Consumer Healthcare companies helping them to streamline their manufacturing processes, eliminate waste, increase work productivity and efficiency, and operate in a state of sustainable compliance. I have extensive experience in managing internal audits, CAPA system, complaint investigation and resolution as well as implementing a robust process for the effective management of document Control. Additionally, I am certified in Six Sigma and Change Management.Key qualifications: • CGMPs, ISO 9001, ISO 13485.• cGMP Training.• CAPA Management.• External Manufacturing Auditing.• Laboratory Operations.• Process Validation.• Quality Control / Quality Assurance.• Stability Laboratory Management.• Annual Product Reviews.• Change Control.• Chemistry Manufacturing and Controls.• Project Management.• Risk Management & Process Improvement.• Root cause Investigations.• Technology Transfer.• TrackWise & CCEx Agile, COMET.

Experience

1. Quality System Expert

   Johnson & Johnson Innovative Medicine

   Oct 2021 — Present · New York, NY, US

   Results-driven and Strategic Quality Professional with 30 years of proven leadership in Quality Systems and compliance management in the pharmaceutical, medical device, consumer healthcare, and biotech industries. Experienced in implementing robust processes that identify compliance gaps and developing strategies for sustainable compliance to corporate policies and governmental regulations, including: FDA/Quality System Requirements and ISO standards for Medical devices

Education

• Seton Hall University

  MPA, Healthcare Management

  1992 — 1995

• Drew University

  MDIV, Divinity

  1998 — 2001

• Pace University

  BS, Chemistry

  1985 — 1989

Skills

• Remediation
• Capa
• Cgmp
• Compliance
• Investigations
• Fda
• Quality Systems
• Quality System
• Sop
• Gmp
• Biotechnology
• Change Control
• Private Investigations
• Medical Devices
• Pharmaceutical Industry
• Regulatory Affairs
• 21 Cfr Part 11
• Biopharmaceuticals
• Chemistry
• Cleaning Validation
• Clinical Development
• Computer System Validation
• Cross-Functional Team Leadership
• Document Management
• Glp
• Gxp
• Healthcare
• Iso
• Iso 13485
• Lims
• Laboratory
• Leadership
• Lifesciences
• Management
• Manufacturing
• Pharmaceutics
• Product Launch
• Program Management
• Quality Assurance
• Quality Auditing