Using Full-Time Consultants to Build a Quality Department: A Staff Augmentation Success Story
How a mid-size biopharma consultants to set up and build a quality department — and tackle projects across its subsidiaries.
Staff augmentation — or hiring full-time consultants to supplement internal staff — offers many use cases and applications in RA/QA.
However, teams that don’t typically make consultants a strategic component of their workforce often struggle to know where and when to hire full-time contractors.
The case study below demonstrates staff aug in action — in this case, helping a mid-size biopharma build a quality department. If you have a need for full-time or part-time contracted resources, don’t hesitate to reach out. Given the budget constraints many teams are experiencing in 2024, these resources have been in high demand.
Be sure to check out our other staff augmentation case studies, too:
Intro and summary
For over three years, The FDA Group has supplied consultants for a mid-sized pharmaceutical company’s quality department, a feat not easily achieved given the company’s unique organizational structure. This company leverages both internal R&D and in-licensing compounds from other pharmaceutical companies, academic institutions, and research organizations. This strategy has enabled them to rapidly advance a diverse portfolio of drugs through the development pipeline.
Adding another layer of complexity, the company employs a business model that involves creating and spinning out subsidiary companies, each focused on specific therapeutic areas or technologies. These subsidiaries operate semi-independently but benefit from the centralized resources and expertise of the parent company.
The FDA Group has been instrumental in this setup, providing full-time consultants to build the central quality team, implement quality systems, and offer ongoing support across multiple subsidiary companies. The team of contracted professionals has played crucial roles throughout the planning and execution phases of the project, offering a flexible, cost-effective workforce that adapts to the company’s fluctuating needs across its subsidiaries.
The challenge
The company approached The FDA Group to secure skilled specialists to build out its quality department.
The company faced several challenges ideally suited for staff augmentation:
Lack of a centralized quality department: The company needed a cohesive quality management system that could support its decentralized structure.
Expertise across multiple subsidiaries: Each subsidiary had different quality management needs, requiring a wide range of expertise.
Fluctuating workloads: The dynamic nature of asset acquisition and divestment led to varying quality management demands.
Specialized skills in quality management, clinical operations, and IT systems: The company required experts in these areas to ensure compliance and efficiency.
Each company subsidiary has a degree of autonomy in deciding whether to use the parent company's quality department or hire its own quality personnel. This structure creates a complex environment where quality needs vary significantly across the organization.
Our solution
In response, we devised a strategy to mobilize multiple external resources as full-time consultants (FTCs) on a long-term basis. This approach provided the company with a flexible, cost-effective workforce capable of addressing its evolving needs.
Consultant A (Quality Lead) was initially brought on as an FTC and later transitioned to an FTE. Their key responsibilities included:
Developing quality transition plans.
Performing gap assessments and risk analysis.
Managing quality integration across manufacturing, clinical, and toxicology areas (GMP, GCP, and GLP).
Developing integration plans for programs across subsidiaries.
Conducting continuous gap assessments for suppliers.
Consultant B (Quality and Clinical Support) focused on supplier qualification and validation, including:
Leading supplier and vendor qualification.
Serving as a validation lead.
Implementing Veeva QMS Vault for supplier qualification and audit management.
Providing quality support across subsidiaries.
Consultant C (Training and QMS Support) specialized in IT systems and training, and was responsible for:
Leading the implementation and management of the Veeva system.
Providing QA support for GxP IT systems across all subsidiaries.
Developing and managing training programs for all new hires.
Offering general QA support for the Veeva system itself.
The results
To date, over these three years, our consultants have achieved significant milestones:
Established a functional quality department: Built a centralized quality management system to support the company's complex structure.
Implemented Veeva QMS Vault: Deployed this system across the organization to streamline quality management processes.
Supported supplier qualification and audit management: Ensured suppliers met rigorous quality standards through continuous qualification and audit processes.
Delivered consistent quality and clinical support: Provided ongoing support across multiple subsidiaries, ensuring compliance and efficiency.
Developed comprehensive training programs: Created and executed training programs for new hires, enhancing the overall quality culture.
Integrated quality processes: Successfully integrated quality processes across technical and functional lines for newly acquired assets.
The engagement’s success is evident in the company’s extended contracts and zero consultant turnover. Company leaders praised the consultants for their overachievement and strongly desired to convert them to full-time employees, highlighting their value and seamless integration.
Company leadership has noted the consultants' value in their ability to work across multiple functional areas and subsidiaries, addressing diverse needs with a smaller, more flexible team. This adaptability was crucial in managing the company’s fluctuating workload and evolving structure.
The staff augmentation model proved an effective solution, offering efficient workload management, particularly amid the unpredictable nature of asset acquisition and divestment
About our staff augmentation model
The FDA Group's staff augmentation model offers a flexible solution for life science companies to access skilled professionals on a full-time contract basis. This model allows organizations to rapidly scale their workforce up or down based on project needs or fluctuating demands without the long-term commitment of hiring permanent employees.
We provide qualified consultants and contractors across various functional areas, including quality assurance, who can work on-site or remotely. This approach enables companies to fill staffing gaps, access specialized expertise, and manage costs more effectively by avoiding additional payroll expenses while still gaining world-class capabilities.
We can fulfill contracted and direct hire resource placement needs in a variety of quality roles and functions, including, but not limited to:
Global/Regional Director
Head of Department
Team Lead
Project Manager
Complaints Handler
Auditor
Technician
Quality Assurance Officer
Site Analyst
CAPA Specialist
Sterility Assurance Specialist
QMS Specialist
Typically, teams engage us for staff aug support when they find themselves answering ‘yes’ to any of the questions below:
Do you have projects that require short-term, intensive regulatory or quality support but do not justify long-term hires?
Are you currently experiencing a backlog of some kind of RA/QA documentation?
Are there critical projects or audits approaching that your current team may not have the capacity to handle?
Are there key personnel in your RA/QA team who are on extended leave or have recently left the organization?
Have you recently acquired new assets or technologies that require specialized quality or regulatory expertise?
Do you need additional support to manage interactions with regulatory authorities or prepare for inspections?
Do you need to hire for a full-time role, but are struggling to capture the scope of the position?
Learn more about our staff augmentation services, read our in-depth introductory guide, and contact us to get the conversation started.
Who is The FDA Group?
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on Quality Assurance, Regulatory Affairs, and Clinical Operations.
With thousands of resources worldwide, hundreds of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee. Learn more.