David Axmann Email & Phone Number

Atlanta, Ga, Us

Atlanta, Ga, Us

Coral Gables, Florida, Us

Ann Arbor, Michigan, Us

Mumbai, Maharashtra, In

-Qualification of all potential new raw material (API and excipient) suppliers, contract manufacturing (CMO) and packaging (CPO) organizations. Conducted on-site audits and ensured the development of appropriate, effective corrective actions. -Created site supplier management process for consumable materials and GMP service providers. Created and maintained approved supplier list and coordinated the creation of approved material inventory codes within SAP.-Subject Matter Expert (SME) for all vendor and supplier related activities and communication. Negotiated supplier Quality Agreements, monitored ongoing supplier performance and managed supplier corrective action requests (SCARs) and internal supplier related investigations. Tracked and assessed change control requests for new suppliers and supplier initiated changes.-Developed site internal audit program. Coordinated annual audit scheduling and served as lead auditor for all internal audits. Scouted internal talent and mentored junior auditors to increase site audit experience.-Regulatory interface during pre-approval inspections (PAI) for multiple generic drug products. Additionally, co-managed back room audit activities and documentation requests.

Chattanooga, Tennessee, Us

-Managed quality assurance, training, safety and inventory operations at 715,000 sq. ft. finished product distribution center.-Hired, managed, trained, motivated and developed twelve direct reports in accomplishing organizational goals within company guidelines.-Developed quality management system (QMS): created written procedures, conducted training, elevated understanding, and measured effectiveness of quality management processes from entry-level to management-level positions.-Ensured site adherence to FDA, DEA, EPA and OSHA regulations and served as lead investigator for customer complaints, quality and safety issues. Developed corrective actions, assigned tasks, tracked resolution and monitored effectiveness.-Managed site inventory activities, including product disposition, annual physical inventory and cycle count program. Published key process indicators (KPIs) to track ongoing performance and analyze trends.

Boston, Massachusetts, Us

-Provided QA support during design, build-out, qualification, operation and regulatory approval of three production facilities.-Internal audit program: Developed annual audit schedule based on assessment of risk, executed audits and worked with department leadership to develop compliant corrective actions.-Material Release - Dispositioned raw materials and consumables for manufacturing and quality control processes according to satisfactory test results and approved specifications.-Product Disposition – Reviewed production batch records, environmental monitoring data and QC test results to support product release. Coordinated product disposition and shipping activities and generated Certificates of Analysis for each lot released.-Served as qualified trainer for quality systems, GMP and inspection management - Authored and delivered training across six sites for technician to executive level employees. -Drove regulatory inspection readiness program – Assembled cross-functional team to identify compliance gaps and to develop, and track completion of, remediation activities.-Provided coaching and guidance to QC, facilities and manufacturing groups during the identification, reporting, investigation and documentation of OOSs, deviations, change controls and CAPAs.-Document Review - Reviewed and approved production batch records, QC assay data, change controls, deviations, CAPAs, procedures, equipment files, log books and validation protocols.

Ingelheim Am Rhein, Rhineland-Palatinate, De

Developed GMP compliant quality systems for pharmaceutical contract manufacturing (CMO) QA group:-Created and maintained a document management system housing over 350 documents utilizing existing company resources; provided access and training to over 200 users worldwide.-Managed pharmaceutical change control system; emphasized accountability while facilitating periodic and ad-hoc meetings with management to ensure timely change approval, closure and follow-up.-Reworked Merial global pharmaceutical deviation management system for all third party and corporate pharmaceutical quality operations; created electronic database for tracking of deviations and resulting CAPAs.-Streamlined archive filing system containing over 4,500 documents; led transition to electronic archives and modified the identification and archival process to reduce document backlog and decrease document retrieval time.-Participated in software validation including protocol creation and test script authoring, approval and execution.

Ingelheim Am Rhein, Rhineland-Palatinate, De

-Provided quality support for US supply chain related to pharmaceutical and biological product distribution.-Responsible for 100% inspection and disposition of returned goods prior to re-distribution.-Performed audits to assess compliance of receiving, storage and distribution activities performed by Merial as well as third party logistics partners (3PL).-Acted as line quality inspector during kitting and packaging / labeling activities.

Ingelheim Am Rhein, Rhineland-Palatinate, De

-Produced viral and bacterial cultures for vaccine production in an aseptic laboratory environment. -Responsible for adhering to GMP guidelines for batch production documentation and equipment cleaning / maintenance.

Bachelor Of Science - Bs, Business Management

Master Of Business Administration - Mba, Healthcare Management