SUMMARY:

• BBA, Bi - Lingual (English & Spanish), Director QA, Compliance and RA professional with more than 20 years of experience in FDA QSR - 21 CFR Part 820, 21 CFR Parts 4, 820, 803, 806, 821, 210 and 211 as well as ISO 13485:2016, MDSAP, 14971, JPAL, CMDCAS, MDD 93/42/EEC for Class I, II and III Medical devices and Pharmaceuticals.
• Experience in managing Quality Engineering, Documentation Control / Change Control, Quality Assurance, Regulatory Compliance Audits (Internal/supplier/Global), Regulatory Affairs (domestic and International), Design Control (NPD and modified products), CAPA Systems and implementing quality systems for organizations.
• Twenty (20) years of progressive experience as a Quality and Compliance professional working in the FDA regulated industry of Medical Devices and Pharmaceuticals with include USA and International auditing, consulting and coaching experience.
• Proficient in writing and presentations skills.
• Lead Auditor, Subject Matter Expert, Coach and Trainer in FDA regulated environments.
• Work solo or on teams providing strategic consultation and/or performing remediation following FDA Compliance Actions (FDA-483s and Warning Letters).
• Team Lead and/or Project Manager/Leader on large or complex projects with multiple work streams (includes the management of resources).
• Ability to audit and assess Device Quality System and/or Drug GMPs to ensure compliance with FDA Requirements.
• Over Twenty (20) years of Technical Experience conducting, managing, and leading internal/external over Forty (40) audits, which included QSR and Pharma internal and external audits of multiple sites, Supplier Audits (laboratories, APIs, Kit Mfg, etc.) and/or cGMP audits. Experience in the area of FDA Inspection Preparation, subject matter expert for FDA inspections, and developing responses to FDA-483 observations.
• Experienced Subject Matter Expert (SME) in the areas of: Complaint Handling, Training, Non-conforming Investigations, Design Controls, Risk Management, UDI, ISO 13485:2016, CAPA, Purchasing & Supplier Controls, Management Controls, Internal / External Audits, MDSAP, Calibration & Preventive Maintenance.
• In-depth knowledge and experience working with 21 CFR Parts 4, 820, 803, 806, 821, 210, 211, as well as ISO 13485, 14971, JPAL, CMDCAS, MDD 93/42/EEC and related International Requirements.

SPECIALTY AREAS INCLUDE:

Proactive Metrics Administration Root Cause Analysis Quality Systems Development & Engineering (FDA CFR Part 820:QSR, CFR Part 211/210/110, Canadian GMP, ISO 13485,ISO 9001,ISO 14971, MDD 93/42/EEC) CE Mark Utilizing Six Sigma/Lean Methodologies OTC Consumer Products CAPA Management Business Process Re - Engineering Forming & Leveraging Vendor/Customer Alliances Managing All Phases of a Product Life Cycle Ability to Engage & Motivate Others Multiple Project Management Design control, design verification / design validation /design of qualification Risk assessment Change management. Trend analysis to generate Tracking and Trending Reports Conduct Internal and Suppliers Quality Audits per ISO 13485 Aseptic filling ETO/Gamma Sterilization

PROFESSIONAL EXPERIENCE:

Confidential, Palm Harbor, FL

Sr. QA Director

Responsibilities:

• Manage the non-conformance system.
• Manage the deviations system.
• Manage the corrective and preventive actions system.
• Manage the internal audits system.
• Perform trending of quality systems in order to identify improvement opportunities.
• Support all departments with root cause analysis, definition of corrective and preventive actions, and in the preparation of the respective records.
• Support the complaints system.
• Support management as quality approver of cGMP documents.
• Responsible for third party audits.
• Manage the execution of external audits.
• Manage and Perform external audits to companies as part of vendor qualification and approval programs.
• Support Laboratory to conduct audits to external contract laboratories.

Confidential, Clearwater, FL

QA Director

Responsibilities:

• Manage the non-conformance system.
• Manage the deviations system.
• Manage the corrective and preventive actions system.
• Manage the internal audits system.
• Perform trending of quality systems in order to identify improvement opportunities.
• Support all departments with root cause analysis, definition of corrective and preventive actions, and in the preparation of the respective records.
• Support the complaints system.
• Support management as quality approver of cGMP documents.
• Responsible for third party audits.
• Manage the execution of external audits.
• Manage and Perform external audits to companies as part of vendor qualification and approval programs.
• Support Laboratory to conduct audits to external contract laboratories.

Confidential, Jacksonville, FL

Director, Quality Assurance and Regulatory Affairs

Responsibilities:

• Manage the non-conformance system.
• Manage the deviations system.
• Manage the corrective and preventive actions system.
• Manage the internal audits system.
• Perform trending of quality systems in order to identify improvement opportunities.
• Support all departments with root cause analysis, definition of corrective and preventive actions, and in the preparation of the respective records.
• Support the complaints system.
• Support management as quality approver of cGMP documents.
• Responsible for third party audits.
• Manage the execution of external audits.
• Manage and Perform external audits to companies as part of vendor qualification and approval programs.
• Support Laboratory to conduct audits to external contract laboratories.

Confidential, Miami, FL

Senior Consultant, Compliance and QA

Responsibilities:

• Manage the non-conformance system.
• Manage the deviations system.
• Manage the corrective and preventive actions system.
• Manage the internal audits system.
• Perform trending of quality systems in order to identify improvement opportunities.
• Support all departments with root cause analysis, definition of corrective and preventive actions, and in the preparation of the respective records.
• Coordinate annual product review for distributed products.
• Support the complaints system.
• Support management as quality approver of cGMP documents.
• Support management in the handling of third party audits.
• Support management conducting external audits.
• Perform external audits to companies as part of vendor qualification and approval programs.
• Support Laboratory to conduct audits to external contract laboratories.

Confidential, Miami, FL

Sr. QA Operations / Engineering Manager

Responsibilities:

• Manage the non-conformance system.
• Manage the deviations system.
• Manage the corrective and preventive actions system.
• Manage the internal audits system.
• Perform trending of quality systems in order to identify improvement opportunities.
• Support all departments with root cause analysis, definition of corrective and preventive actions, and in the preparation of the respective records.
• Support the complaints system.
• Support management as quality approver of cGMP documents.
• Responsible for third party audits.
• Manage the execution of external audits.
• Manage and Perform external audits to companies as part of vendor qualification and approval programs.
• Support Laboratory to conduct audits to external contract laboratories.

Confidential, Puerto Rico

QA Director

Responsibilities:

• Manage the non-conformance system.
• Manage the deviations system.
• Manage the corrective and preventive actions system.
• Manage the internal audits system.
• Perform trending of quality systems in order to identify improvement opportunities.
• Support all departments with root cause analysis, definition of corrective and preventive actions, and in the preparation of the respective records.
• Coordinate annual product review for distributed products.
• Support the complaints system.
• Support management as quality approver of cGMP documents.
• Support management in the handling of third party audits.
• Support management conducting external audits.
• Perform external audits to companies as part of vendor qualification and approval programs.
• Support Laboratory to conduct audits to external contract laboratories.

Confidential, Tampa, FL

Senior Quality Assurance Manager

Responsibilities:

• Manage the non-conformance system.
• Manage the deviations system.
• Manage the corrective and preventive actions system.
• Manage the internal audits system.
• Perform trending of quality systems in order to identify improvement opportunities.
• Support all departments with root cause analysis, definition of corrective and preventive actions, and in the preparation of the respective records.
• Coordinate annual product review for distributed products.
• Support the complaints system.
• Support management as quality approver of cGMP documents.
• Support management in the handling of third party audits.
• Support management conducting external audits.
• Perform external audits to companies as part of vendor qualification and approval programs.
• Support Laboratory to conduct audits to external contract laboratories.