Experienced and dynamic leader in CG&T space with a proven track record for improvements in quality, delivery, and continuous improvement. Key player in multiple manufacturing readiness projects across various departments. As a Manufacturing Director, Sara is directly responsible for all phases of clinical readiness as well as commercial readiness including facility design and remediation, processing and manufacture, environment, quality, delivery, and auditing. Sara served as Site Leadership Representative for creation or implementation of any new process or procedure, ensuring Quality by Design.  Passion and strengths both align to process improvements and operational efficiency utilizing process mapping, tracking and trending, metrics, and visual management tools. Sara holds a double major in Electrical Engineering and Mathematics from the University of Mississippi.  

 

• Created and implemented sitewide visual management tools resulting in marked improvements in on-time quality system closure.  

• 80% reduction of nonconformance generation in manufacturing and operations. 

• Co-created the investigation team to perform root cause analyses on unique environmental deviations and create cross-contamination SOP. 

• Process mapped incoming product (leukapheresis packs) through QA release for forward processing identifying gaps and opportunities for improvement; Developed procedure to define new process. 

• Created and implemented alarm response plans and served as SME for facility design. 

• Piloted the regulatory audit/ inspection readiness plans and led War Room for a successful QP audit and multiple successful client audits. 

• Acted as core team member and Operations Leadership Representative for creation of sitewide Nonconformance processes and SOP, CAPA process and SOP, and Change Control processes and SOP. 

• Authored Multi-Use Suite Policy outlining the process for performing multiple manufacturing operations (including multiple client processes) in a single suite including product line segregation, time/ space separation, labeling, visual management coding, etc;  Defended SOP during regulatory inspection. 

• Developed Gowning Qualification procedure, Operator Qualification procedure, Process Simulation procedures/ protocols and reports, Aseptic Technique procedure, Personnel Flow procedure, and Environmental Alarm Response procedures.