Case Study: Quality Management System

Synopsis

A biopharmaceutical company specializing in the development of gene therapies for the treatment of genetic and rare diseases was facing a challenge. Several drug candidates in the company’s impressive late stage clinical program were moving towards commercial approval. However, the existing quality system would need to be revamped to handle the potential marketing of multiple approved biologic and drug products. The company needed expertise to develop a more robust quality system that fit the commercial needs of the growing organization. It also needed a resource partner that could develop project plans, supply the top-level consultants needed to address the additional workload, and manage the resources and deliverables to ensure the development and implementation of the new quality management system.

Challenges

The additional demands of commercial expansion placed on the company’s quality system, quality assurance, and quality control teams created both bandwidth issues and expertise gaps. Moreover, the expansion of the quality system would require significant investment in time and resources including process mapping and development, documentation creation, systems integration and improvements, training and other critical activities. The company would also need time to find, recruit, and onboard permanent employees for newly identified positions.

Actions

Black Diamond Networks (BDN) reacted quickly, collaborating with the client to develop a comprehensive strategy identifying the compliance gaps and associated risks, understanding the needs of the organization, and building out the quality system. BDN developed the project plans, identified and addressed the resource gaps, managed the resources and milestones, and ensured the execution of the project. BDN also sourced contract-to-hire and consulting resources to bridge the gap until permanent hires could be transitioned in the new roles created by the changes to the quality system. In total, BDN supplied over 20 professional resources with the experience, expertise, and drive to ensure the success of the project. Results Black Diamond Networks aided in the design, development, and implementation of an improved quality system covering pre-clinical, clinical, and commercial operations. BDN’s solution created a lasting impact by delivering improved processes, more compliant procedures, stronger documentation, and better trained and prepared personnel.