Rod Freeman Email & Phone Number

Oceanside, CA, US

Santa Monica, California, US

Site lead for Quality Assurance, Quality Systems, and Quality Engineering functions. Established Site Risk Register and Risk Management program. Authored Site Master File and Section 3.2.A.1 for FDA filing. Lead FDA Type C Meeting Workstream and drove creation and implementation of Contamination Control Plan. Host domestic and international regulatory.

Santa Monica, California, US

Responsible for commissioning, qualification, validation, and risk management for facilities, utilities and equipment for a multi viral vector manufacturing facility. Lead CQV team consisting of 14 contract and full-time resources. Accountable for Computer System Validation (CSV) program and Data Integrity. Oversee required Corrective and Preventative.

Washington, District Of Columbia, US

Adjunct Professor for the Johns Hopkins Krieger School of Arts and Science Advanced Academic Program teaching "Introduction to GMP" and "International Regulatory Affairs" for the Regulatory Science and Biotechnology programs.

Brea, California, US

Global Process Owner (GPO) for Validation, Equipment and Facilities, and Production and Process Controls (P&PC) Global Quality Systems. Drive improvements in Global Quality Systems using the Danaher Business System (DBS) to reduce waste and increase efficiency while maintaining compliance. Partner with Local Process Owners (LPO) representing 19 sites.

Brea, California, US

Manage validation program for in-vitro diagnostic reagent manufacturing site. Oversee site Calibration Program and Instrument repair as well. Actively improve processes and quality systems surrounding and supporting the engineering and validation efforts. Extensive experience with ISO 13485, 21CFR 210, 211, and 820. Inspection experience includes FDA.

Adjunct Faculty Instructor in Bachelor of Science Biotechnology Manufacturing program.

Tel-Aviv, IL

Manage facilities department for multi-building parenteral manufacturing campus. Responsible for day-to-day facility and utility operations as well as facilities maintenance process improvements and streamlining. Extensive experience with quality systems to support production and regulatory inspection interaction with both US and international agencies.

Abbott Park, Illinois, US

Responsible for creation and implementation of validation policies and procedures, and gap analysis of legacy validation efforts. Manage contract validation staff.

London, GB

Prepared and provided in-depth Pharamceutical Water System training programs for public and company-specific events. Promote active audience participation and provide real-life experiences in the training session.

New York, New York, US

Establish validation policies and procedures for global R&D site to support clinical manufacturing. Manage contract validation staff.

Indianapolis, Indiana, US

Responsible for design of WFI system for parenteral manufacturing plant. Manage contract design engineers.

New York, New York, US

Responsible for operation, maintenance, and improvement of all central utilities for a large GMP liquids manufacturing facility. Expertise in Pharma Water Systems. Ten direct reports.

New York, New York, US

Validation lead for Pharma Utilities, and support general validation efforts including process, packaging, facility, cleaning, and computer.

Consulting Validation Engineer position. Site project lead, and support general validation efforts including process, packaging, facility, cleaning, and computer.

Inside Technical Sales Engineer for Rep Firm serving semiconductor and biotechnology industry.

Analytical chemical testing of raw materials and finished products to support solid oral dosage manufacturing. Support development of analytical methods, method validation, and cleaning validation.

Master Of Science (Ms), Regulatory Science

B.S., Chemical Engineering