FDA DSCSA Track & Trace Serialization Program
Serialization Delivery Project Manager (Former Employee) – Lake Forest, IL – November 2, 2017
Serialization Work stream PM responsibilities involved responsibilities that combined Scrum Coach, Scrum Master, Program Director, Operations Director, Project Manager, Security, Compliance, Regulatory awareness and most important Alliance Building skills.
While in a leading role, I learned more about 21 CFR 11 and FDA validation requirements for tracing and traceability of pharmaceutical drugs.
Akorn Inc is a mid-sized but growing Pharma Company and the work culture was transitioning towards mature business practice that also exercised legacy business practices that valued employee contributions and compassionate for employees welfare. Aside from leadership, this is one of the main reasons that Akorn seemed to thrive and grow in a very competitive market segment.
The hardest part of the job was the size of the project team and concurrent activities and keeping communications and scheduling harmonized. specially when there was a dependency with solution partners that provided newly designed and manufactured logistics materials handling hardware and also was developing new big-data application management systems..
Being able to work with autonomous teams, work streams and adherence to stringent compliance and regulatory parameters requires disciplines to details, collaboration and a level head as patience will be pushed to its limits.
Open minded to employee idea's and contributions
initiating too many IT project concurrently with limited staffing resources