Partner to guide and support the Quality Department’s general FDA compliance activities including compliance auditing and regulatory assistance.

Provide specialized guidance to ensure compliance with all applicable Federal and State requirements regulating the manufacturing and distribution of drug, device and food products.

Develops and maintains strong partnerships with operations, distribution, and sales leadership in assigned region to develop, champion, implement and sustain Quality and FDA Compliance strategies, policies, standards, guidelines, processes and optimized practices. Work with global peers to develop optimized practices as it relates to the overall quality & compliance system.

Actively participates in the development of training materials and trains members of the local Quality Control Unit (QCU) in areas of Current Good Manufacturing Practices (cGMPs) with the shared understanding of the ”WHY” we do what we do.

Performs physical audits annually, and monthly paper audits of drug, device and food manufacturing facilities with the emphasis of analyzing the process to ensure that it conforms to Airgas Medical Drug gas SOPs.

Represent Airgas during on-site inspections by the FDA, other government agencies, and customers.

Maintain specialized guidance regarding current and developing food, drug, and standards and regulations and how they impact Airgas’ business and quality system.

Assist in assuring and sustaining compliance with all regulatory requirements associated with medical products and processes.

Review and approve validation protocols and final reports.

Assist plants with regulatory and customer audits of manufacturing facilities.

Conducts follow-up reviews to ensure the completion of required corrective actions and continued plant compliance to SOPs.

Drafts corrective action responses associated with state, federal a