Meghan Leonard Email & Phone Number

Columbus, Ohio, Us

- As Site Quality Head, manage the entire Quality Unit; 7 direct and 49 indirect reports, including Quality Assurance and Quality Systems, Quality Engineering and Validation, Supplier Quality Management, and Quality Control personnel, to support cGMP manufacturing and testing of clinical trial material for gene therapy programs- Develop a phase-appropriate cGMP compliant quality management system to support contract development and manufacturing for Forge’s Clients, including an internal early phase clinical gene therapy program- Implement and maintain Veeva Vault Quality, cloud-based software that manages quality processes, content, and training, and provides a single authoritative source of quality information, including QualityDocs, Station Manager, Training, QMS, and LIMS- Oversee the GMP operations at the Grove City manufacturing and testing facility and ensure adherence to corporate policies/standards and applicable GMP regulations, which includes product disposition of Client products and adherence to regulatory requirements to ensure product quality- Accountable for providing compliance and strategic guidance during the design and qualification of facility expansions

Columbus, Ohio, Us

Columbus, Ohio, Us

Cleveland, Oh, Us

- Managed a Quality team of 8+ direct and indirect reports, including Validation and Supplier Quality, to support site goals of cGMP manufacturing of clinical trial material and inspection readiness- Developed a phase-appropriate cGMP compliant quality management system to support in-house manufacturing for Abeona’s ongoing Phase 3 clinical trial of EB-101, a gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB)- Implemented TrackWise Digital cloud QMS software, an electronic quality management system with integrated modules that work together to support quality and compliance, including document (DMS) and training (TMS) management- Provided technical support regarding the revision or implementation of QMS documentation, including procedures, work instructions, and forms- Guided and supported project teams to ensure key project timelines and deliverables were met on time or ahead of schedule

Cleveland, Oh, Us

- Manage a Quality team of 8+ direct reports to support site goals of on time product release and on time complaint, CAPA, and investigation closure- Lead site quality data analysis and management review activities, including summarizing the state of the organization, overall health of the quality systems, and providing recommendations for corrective actions- Manage annual FDA establishment registration (21 CFR 807), and maintain device registration and listing information- Effectively represent the site for certification assessments (i.e., ISO 9001, ISO 13485 Medical Devices, EXCiPACT) and regulatory inspections (e.g., FDA)- Lead customer and regulatory audits, including audit preparation, documentation, follow-up, and closure activities- Provide technical support regarding the revision or implementation of QMS documentation, including procedures, work instructions, and forms- Guide and support project teams to ensure key project timelines and deliverables are met on or ahead of schedule

Mentor, Ohio, Us

- Managed a Quality and Regulatory team of 3 direct reports to support site goals of on time product release and on time complaint, CAPA, and investigation closure- Led site quality data analysis and management review activities, including summarizing the state of the organization, overall health of the quality systems, and providing recommendations for corrective actions- Managed annual FDA establishment registration (21 CFR 807), and maintained device registration and listing information- Effectively represented the site for certification assessments (i.e., ISO 13485 Medical Devices) and regulatory inspections (e.g., FDA)- Obtained product registrations domestically and internationally to support sales growth, which included the authoring and submission of a Special 510(k) to FDA, which was accepted in 29 calendar days- Led recall activities, including notification and submission to FDA and public notification- Achieved key project timelines and deliverables to support new product launch, including leading cleanroom qualification activities and contract sterilization validation activities- Represented Quality and Regulatory functions as an appointed member to the company Board

Raritan, New Jersey, Us

Quality Systems Lead, Operations (promoted, 2014)Project Manager, Validation / Remediation (2014)- Managed an Operations investigation team of 3+ direct reports to support site goals of on time closure of events and deviations, including supporting continuity of supply to eliminate drug shortage through closure of events early to support batch disposition and release- Developed and led key project timelines and deliverables to support the site decommissioning process, including associated project plans and governance, as well as developed templates for GxP documents (e.g., decommissioning plans, risk assessments, GxP decommissioning protocols, GEP decommissioning protocols)- Authored new SOPs and SOP revisions, change controls, and protocols needed to address compliance gaps and events

Ingelheim Am Rhein, Rhineland-Palatinate, De

- Supported consent decree remediation for management review and APR work streams by way of defining the cGMP standard and implementation planning- Provided project management, complex problem solving, and technical design expertise required to effectively lead and manage functional and cross-functional Change Control, Engineering, and Validation projects- Coached and mentored 3-40+ staff members by providing quality and technical support, and routinely served as a delegate for members of the management team- Managed departmental metrics, including training compliance metrics for 40+ staff members and 60+ contractors, and led departmental process improvement initiatives- Developed and led key project timelines and deliverables to support an implementation plan and SOP for electronic method of monitoring requalification and periodic review validation activities, including the compliant transfer of over 500 systems (equipment, facilities, utilities) into an electronic database- Effectively represented the Validation department’s cGMP documentation during global regulatory inspections and customer audits

Ingelheim Am Rhein, Rhineland-Palatinate, De

Senior Specialist, Change Control (promoted, 2010-2012)Specialist, Change Control (promoted, 2009-2010)- Provided project management, complex problem solving, and technical design expertise required to effectively lead and manage functional and cross-functional Change Control, Engineering, and Validation projects- Coached and mentored 3-40+ staff members by providing quality and technical support, and routinely served as a delegate for members of the management team- Effectively represented the Change Control department’s cGMP documentation during global regulatory inspections and customer audits, including an industry-first three agency (FDA, MHRA, and TGA) joint inspection in 2011- Developed and maintained SOPs and other tools necessary for the success of the change management program, and developed and delivered change management program training to all user groups- Processed, on average, 200+ change control records per year (about 50% routine and 50% deemed site-critical, emergency, or urgent) as the Quality review and approval, with areas of expertise that included equipment, utilities, facilities, and validation

Ingelheim Am Rhein, Rhineland-Palatinate, De

- Direct leadership, including performance management and coaching, supervising a team of 10+ chemists and specialists working to formulate bulk solutions for aseptic filling of sterile injectable drug products for existing commercial products, development, ANDAs, and validation activities- Reviewed batch records prior to submission for batch disposition- Collaborated with Process Development on the formulation of scale-up drug products to ensure successful commercial manufacturing- Collaborated with Validation on the formulation of drug products to support validation activities, including media fills and manufacturing process validation- Collaborated with and provided technical oversight to other areas of manufacturing (e.g., Equipment Prep, Sterile Filling, and Lyophilization) to ensure conformity with product requirements, as well as schedule adherence- Collaborated with Quality and Regulatory to identify and assess change management records, investigations, and CAPAs to ensure inclusion of relevant technical details and suitable risk assessments

Ingelheim Am Rhein, Rhineland-Palatinate, De

Ingelheim Am Rhein, Rhineland-Palatinate, De