Quality Department Development and Long-Term Staff Augmentation

For over three years, The FDA Group has been dedicated to supporting a mid-sized pharmaceutical company with a unique organizational structure in developing and maintaining its quality department. This case study details how we helped the company overcome its quality management challenges through strategic staff augmentation.

In collaboration with the company's leadership, we developed a strategy for mobilizing external resources to address these needs. This included:

• Quality Lead (Consultant A): Initially placed as a full-time contractor (FTC) and later transitioned to a full-time employee (FTE), Consultant A developed quality transition plans, performed gap assessments, and managed quality integration across manufacturing, clinical, and toxicology areas.
• Consultant B: Provided supplier and vendor qualification support, served as a validation lead, implemented Veeva QMS Vault, and offered quality support across multiple subsidiaries.
• Consultant C: Led the implementation and management of the Veeva system, provided QA support for GxP IT systems, developed training programs, and offered general QA support.

Our flexible staff augmentation model enabled the successful establishment of a functional quality department, implementation of the Veeva QMS Vault across the organization, and ongoing supplier qualification and audit management support.

Read our free case study to learn how The FDA Group supported the company in building and maintaining a quality department through a flexible, cost-effective staff augmentation model, allowing the company to manage fluctuating workloads and evolving organizational needs effectively.