Director of Compliance - South Division

Airgas•Kennesaw, GA

28d•Hybrid

About The Position

The Director of Compliance will be responsible for providing oversight for the division’s compliance with Food and Drug Administration (FDA) and Department of Transportation (DOT) regulations as well as internal operating procedures. This position will coordinate activity with Division Vice President, Safety and Compliance; Regional Safety Directors and field safety personnel as it relates to FDA and DOT compliance for the South Division companies. Ensures consistency across the division with FDA and DOT rules and regulations and enables line management to administer day-to-day responsibilities with regard to such. While the primary location for this role is in the Atlanta, GA area (Kennesaw), the physical location for this role is flexible across the Airgas South Division. Candidates residing near a major travel hub to support the 50% travel requirement are highly preferred.

Requirements

Significant FDA and/or industry operational experience with focus on rules and regulations regarding the production and distribution of regulated products.
Subject matter expert/strong aptitude to obtain the knowledge of FDA gases and the handling, storage and distribution of such across the division.
Significant DOT and/or industry operational experience with focus on rules and regulations regarding DOT activity
Experience with multi-site, hands-on operational oversight, specifically with implementing policies and training field personnel.
Demonstrates the ability to work, influence and coach in a matrixed organization to meet the needs of the local, regional and division managers and drive continuous improvement.
Ability to manage multiple priorities.
Ability to travel ~50% of the time throughout division.

Nice To Haves

Strong familiarity with the industrial gas industry
Exposure to and understanding of other regulatory requirements
Professional certification

Responsibilities

Work closely with regional staff to ensure FDA and DOT compliance at each facility within the division
Oversee and assist in the administration of required FDA licensing and registration to include federal medical, federal food, federal device as well as state requirements
Conduct FDA audits throughout the division
Conduct calibration FDA audits with regional field safety to ensure consistency throughout each regional company
Work with the Division VP of Safety and Compliance to coordinate with the SAFECOR FDA manager and act as liaison between SAFECOR and regional companies within the division
Ensure procedural revisions are effectively communicated throughout the division for both FDA and DOT requirements
Represent the division on SAFECOR FDA and DOT leadership committees alongside the Division VP of Safety and Compliance
Provide support and training for facilities to improve compliance and understanding of FDA and DOT production and distribution requirements
Maintain list of registered facilities and verify completion of annual FDA audits
Compile monthly report on status of FDA location audits, 483 activity, roadside inspections, DOT site audits and DDM status
Update (as events occur) SAFECOR FDA violation tracking spreadsheet
Maintain list of registered facilities with DOT and FDA to include specific activities such as products filled and testing (RIN, VIN, K-Stamp)
Review completed FDA audits and corrective actions, assist regions in taking action as appropriate.
Coordinate with regional safety teams and track corrective actions to closing
Work with Division VP of Safety and Compliance to coordinate and champion regulatory response to include state inquiries, 483 response, customer complaints and other correspondence as required
Represent and assist regional safety management and local management with on-site regulatory and/or customer inspections
Implement system to monitor DOT compliance at branch level. Conduct periodic audits as necessary. Ensure consistency across the division
Oversee DOT file process for division and ensure information is updated in a timely manner
Maintain DOT accident register for all regions within the division. Communicate information to Division VP of Safety and Compliance to ensure proper internal reporting
Work with Division VP, Safety and Compliance to audit division DOT compliance at least on annual basis
Participate in accident review calls within division as necessary
Maintain and report information regarding roadside inspections
Perform other duties and projects as assigned
Participate in review and approval process of medical part number requests from field