Matthew E. Email & Phone Number

El Segundo, California, United States

Increasing scope and responsibility through leadership and supervision of both direct and indirect reports (40+) to support all quality operations at multiple internal manufacturing sites in both California and Colorado. The internal manufacturing sites produce both autologous and allogeneic cell therapy products, second generation adenovirus vaccines, and saRNA vaccines. Also serve as quality oversight of contract manufacturing organizations supporting the production of Drug Substance and Fill/Finish Operations. Current and previous responsibilities include management of QA Floor Support, Batch Disposition, Raw Material Inspection and Disposition, Quality Engineering, Alliance Quality (External Manufacturing) and Product Quality with Director and Associate Directors reports.

El Segundo, California, United States

El Segundo, California

Santa Monica, California

Broad scope of responsibility as the corporate quality systems manager for Deviation Management, Change Management, Corrective and Preventive Action (CAPA) program, Effectiveness Verification, and Quality Management Review (Metrics). Established weekly governance meeting to manage at risk and late quality records. Managed the Global Change Control Board and created a harmonized change control template for use across both corporate and manufacturing sites. Led the implementation of process improvement efforts for Deviation Management and the CAPA program resulting in efficient and compliant quality system processes. Launched the global Quality Systems Forum for all US manufacturing sites and corporate quality systems personnel.

San Diego, California

Sabbatical from career in pharmaceutical quality assurance management in order to transfer to California and invest in bettering the lives of Oceanside residents as a full-time volunteer. My focus as an Americorps member was to help create a safe and educational environment for at risk youth and support efforts to foster self reliance through volunteer engagement at La Casita.

Indianapolis, Indiana Area

Broad scope of responsibility for all quality systems within Lilly USA (Sales and Marketing) to establish risk based and efficient processes that were right sized based upon regulatory requirements specific to pharmaceutical sales and marketing. This includes peer coaching and mentoring, as well as, influencing senior leadership within the quality organization and various functional support groups to ensure all systems were effective, compliant and sustainable.* Established a cross-functional forum to discuss Quality Systems and provide an opportunity for shared learnings associated with work activities and develop action plans to address the most critical observations, as well as, identify and implement process improvements.* Served as the diversity and inclusion team chair for the central quality organization (250+ employees) to develop a 3-year vision and implementation strategy to ensure awareness, understanding and ultimately productive actions specific to improving diversity and inclusion within the organization and across the company. * Harmonized deviation management process resulting in the reduction of procedures, supporting documents and enhanced training to ensure effective and consistent execution of processes.* Established risk based deviation leveling to facilitate right-sized investigations and the corresponding efforts to correct and prevent reoccurrence. Additionally, created a process for managing and documenting specific issues within the US Diabetes Sales force resulting in the elimination of formal deviation investigations. * Created new and/or enhanced quality systems to ensure accountability for required tasks and a sustainable process within the organization for consistent and reliable execution.* Critical external deviation management resulting in a swift risk mitigation strategy followed by a methodical and thorough investigation to determine the root causes and a robust CAPA plan.

Indianapolis, Indiana Area

Increasing scope and responsibility through leadership and supervision of both direct and indirect reports (26+) to support the parenteral aseptic manufacturing of high quality drugs and oversight to ensure competitive compliance. Scope of accountability includes: Manager (October 2012-May 2013): QA Regulatory, Facilities/Utilities/Maintenance/Engineering, QA Data Stewards, QA Floor SupportManager (May 2013-September 2015): QA Batch Disposition and Complaint Management. *Established a cross-functional batch disposition process team and led the team to establish governing procedures, identify and prioritize process improvements, manage daily workload and monitor current process capability. * Facilitated the development and management of the change agenda to meet site objectives and served as the liaison between commercial and clinical trial batch disposition to streamline batch disposition processes and eliminate duplicate work activities.* Identified inconsistencies and coordinated the resolution of global batch disposition metrics through escalation of the issue to executive management, soliciting feedback from global peers to develop an appropriate solution and support in the implementation of the global solution.* Quality approver for all manufacturing equipment and processes associated with formulation and equipment preparation activities, such as, cleaning/sterilization validation, air flow pattern testing, equipment installation/operational qualification and process validation. Additionally, quality approver for new manufacturing site to perform new cartridge filling and manufacturing activities.* Supported external regulatory and corporate audits in various capacities including lead host, lead scribe and SME. * Utilized six sigma tools and methodology to increase the capability and capacity of the organization including a project that eliminated 1000+ hours of work with the quality organization.

Indianapolis, Indiana Area

Supervised, educated and served as an example and resource for a diverse team of quality professionals (8+) supporting 24/7 day-to-day operations, including both traditional aseptic filling, RABS, and isolator technology within both a vial and prefilled syringe presentation. Primary scope of influence was specific to QA floor support within formulation, equipment preparation, and freeze dry operations. * Owned and enhanced quality check process to improve documentation and accountability for issue resolution and created a sustainable process through use of an existing electronic solution.* Established rules and guidelines for quality support activities to ensure consistent and effective management of work processes and employee assignments. * Created QA floor support on-boarding roadmap, as well as, enhanced floor support training within area of focus.

Indianapolis, Indiana Area

Actively provided primary floor support within 3 distinct manufacturing areas with robust knowledge and experience in floor support activities, as well as, quality engineering and computer system validation certification. Project manager supporting the implementation of key quality system changes and served as the Interim Manager for incoming materials management.* Established the quality framework associated with a new format and style for standard operation procedures, supporting documents, product manufacturing instructions and training with a focus on Human Error Prevention within clinical trial manufacturing.* Project manager for implementation of various quality systems and procedures, such as the implementation of a new quality hold system, retirement of old quality hold system and harmonized line clearance change within parenteral aseptic manufacturing and packaging operations.* Established quality engagement team structure, served as Quality Engagement Team Coordinator and site quality liaison. Co-led initiative to provide an opportunity for 1800+ employees, family and friends to tour the facility which included oversight for the creation of a professional video depicting the various processes at the parenteral site.