Johnny Leon, Mba Email & Phone Number

Morgantown, West Virginia, United States

• Managed a team of nine (9) direct and indirect reports in compiling the Annual Product Reviews (APRs) for all products manufactured, packaged, tested, or released at the Morgantown, WV manufacturing facility while maintaining a 100% on-time completion rate.• Served as Project Manager for ten (10) Morgantown Remediation Program workstreams requiring project charters, weekly updates and progress reports while coordinating with leaders from multiple levels of the organization to finalize evidence of completion.• Led and supported FDA and Internal Audit readiness initiatives while the site was under a Warning Letter by providing Subject Matter Expert (SME) training and preparation, identifying key team members to participate in the inspection, interfacing one on one with inspectors and managing the coordination of activities during and after the inspection including over 200 Corrective Actions and response commitments.• Led monthly Quality Council meetings where key performance indicators were presented to Site, Regional and Global Leadership for review. Managed a direct report who collected and maintained site metrics while creating presentations to communicate key trends clearly and effectively.• Escalated over 100 Critical Quality Events to Site, Regional and Global leadership for review and led the drafting, review, and submission of Field Alert Reports (FAR) to the FDA. Trained employees on the FAR preparation and submission process. • Served as final quality approval for over 200 Audit CAPAs and commitments as well as procedure, work instruction and template revisions.

Morgantown, Wv

• Managed a team of nine (9) direct and indirect reports in compiling the Annual Product Reviews (APRs) for all products manufactured, packaged, tested, or released at the Morgantown, WV manufacturing facility while maintaining a 100% on-time completion rate.• Served as Project Manager for ten (10) Morgantown Remediation Program workstreams requiring project charters, weekly updates and progress reports while coordinating with leaders from multiple levels of the organization to finalize evidence of completion.• Led and supported FDA and Internal Audit readiness initiatives while the site was under a Warning Letter by providing Subject Matter Expert (SME) training and preparation, identifying key team members to participate in the inspection, interfacing one on one with inspectors and managing the coordination of activities during and after the inspection including over 200 Corrective Actions and response commitments.• Led monthly Quality Council meetings where key performance indicators were presented to Site, Regional and Global Leadership for review. Managed a direct report who collected and maintained site metrics while creating presentations to communicate key trends clearly and effectively.• Escalated over 100 Critical Quality Events to Site, Regional and Global leadership for review and led the drafting, review, and submission of Field Alert Reports (FAR) to the FDA. Trained employees on the FAR preparation and submission process. • Served as final quality approval for over 200 Audit CAPAs and commitments as well as procedure, work instruction and template revisions.

Morgantown, Wv

• Prepared and conducted over 20 GXP internal audits for the entire Mylan Pharmaceuticals Inc., Morgantown, WV site including issuing audit reports, providing recommendations, and facilitating corrective actions to closure.• Managed the document control room during multiple Health Authority and Third-Party audits which required organizing audit requests, preparing SMEs for interviews, interfacing 1 on 1 with inspectors and leading auditors on tours of the facility.• Authored the Quality-related sections for over 20 Product Control Restart Program reports used to re-start manufacturing of products in a validated state. • Authored and approved SOPs, CAPAs, TrackWise Internal Audit reports and training documents.

Morgantown, Wv

• Interfaced with site operation owners to collect, analyze, and report key data related to various site quality performance indicators weekly and monthly. • Implemented action plans to address issues based on trends identified.• Compiled over 70 Annual Product Reviews for individual product lines, which detailed the performance and status of products manufactured at the site. • Performed statistical analysis for product performance, including control charts and capability analysis utilizing Minitab and Microsoft Excel.• Trained 5 new members of the Annual Product Review group to become proficient in writing and compiling reports.• Assisted site leadership and subject matter experts during 3 Health Authority audits and 1 Internal Audit by providing documents to the auditors and leading the auditors on tours of the facilities.

Morgantown, Wv

• Directly supervised over 30 union employees in day-to-day manufacturing operations.• Ensured that all SOPs, GMPs, and OSHA safety regulations were always observed.• Developed production schedules and staffed labor optimally to ensure maximum output while maintaining quality standards.• Tracked workforce allocation weekly and adjusted schedules to optimize staffing and production• Lead the cleaning efficiency team and actively reduced clean times and cleaning failures.• Audited manufacturing areas and implemented recommendations which led to the reduction of total foreign material-related investigations by almost 50%

Morgantown, Wv

• Formulated test batches by conducting complex calculations and recording all physical testing data for individual tablets.• Took apart, cleaned, and pieced back together pieces of heavy, stainless steel equipment• Performed scale-up calculations and authored reports for batches being manufactured on a commercial scale

Fairmont, Wv

• Landscaped various public and private homes, schools, and businesses• Assigned jobs that required team-oriented communication and cooperation including building walls, operating heavy machinery and completing large-scale projects

Master Of Business Administration (M.B.A.), Operations Management, Finance, Business Technologies, 4.0

Science-Business, Biology/Biological Sciences, Business, Anthropology

Education record