The Consultants That Stayed: How Full-Time Experts Rebuilt a Company's Quality System
A clinical service company's two-year journey with The FDA Group reveals the strategic power of long-term consulting engagements.
Staff augmentation — or hiring full-time consultants to supplement internal staff — offers many use cases and applications in RA/QA. But as we see time and again, 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 augmentation in action — in this case, helping a large clinical service company address critical gaps in its quality management system and build out its quality and pharmacovigilance functions.
The experts we staffed into the Quality department continue to serve vital roles in managing the company’s Quality and pharmacovigilance function, serving as internal full-time resources through a convenient, cost-effective workforce model that circumvents the administrative costs and burdens of traditional hiring.
If you need full-time or part-time contracted resources, don't hesitate to contact us. Given the regulatory challenges and budget constraints many teams are experiencing in 2024 and the flight of some of the industry’s best talent into the consulting pool, these flexible, expert resources have been in high demand.
The problem
As the company prepared for upcoming vendor audits, it discovered several gaps in its quality system. Lacking the in-house expertise to address these issues, the company faced two challenges:
Developing a strategic assessment and action plan
Providing practical, day-to-day oversight of the plan's implementation
This situation called for external support to devise an improvement strategy and implement it hands-on. The company needed experts who could plan the strategy (a traditional consulting role), implement it, and manage its ongoing implementation.
After engagisn us to see if our network and model could deliver, we provided two drug safety and quality system experts with decades of experience in regulated life sciences. These consultants brought direct experience in managing pharmacovigilance and broader quality assurance programs, and extensive knowledge of remediation and regulatory preparedness.
Our experts were tasked with planning and executing the necessary work while also providing ongoing support as augmented internal resources.
The staff augmentation solution
Our staff augmentation engagement unfolded in three main phases:
Phase 1: Strategic Assessment
One insourced resource assumed a Manager/Director-level role
Conducted a comprehensive assessment of the company's QMS
Developed a strategy for quality system improvement
Phase 2: Documentation Overhaul
Added a second contracted resource as a documentation specialist
Revised and rewrote procedures to ensure full compliance
Implemented updated documents throughout the QMS
Phase 3: Expanded QA Leadership
After completing the initial documentation project, we broadened the scope of our support.
Initial Addendum:
Created, reviewed, and updated SOPs based on operational/technical needs
Collaborated with senior leadership to identify needs for new SOPs
Developed staff training programs on SOPs
Assisted in developing change control processes and guidelines
Supported internal/external audits, corrective actions, and follow-ups
Second Addendum:
Formally assigned the role of "QA Director" to our contracted resource
Expanded responsibilities to cover all assurance activities and pharmacovigilance projects
Throughout this second project addendum, our resources delivered all kinds of additional work projects, including:
Implementing and promoting the use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures (and assume accountability for the deliverables).
Ensuring compliance of operations with governing regulatory requirements.
Nurturing and sustaining an environment of continuous learning.
Providing ongoing high-level reviews of the pharmacovigilance services, which included individual case safety reports (ICSRs), aggregate reports, signal detection reports, risk management plans, literature searches, Medical Information, and Product Quality complaint reporting.
Identifying quality trends and conducting detailed root cause assessments.
Preparing Non-Compliance Reports and managing the CAPA process.
Ensuring that CAPA results are tracked, implemented, and producing documentary evidence to that effect in coordination with the project managers.
Conducting process reviews in coordination with the development of process standards for measurements and process improvements.
Results
The approach combined traditional consulting expertise with practical execution through contingent staffing, delivering both immediate project results and long-term value.
Key outcomes include:
Successful audit readiness: The company completed its initial project objectives and prepared itself for vendor audits.
Expanded role in Quality function: Experts transitioned to larger roles in ongoing quality operations, such as applying extensive drug safety experience to lead the pharmacovigilance program.
Long-term engagement: Both resources secured extended full-time contingent staffing arrangements.
The client reported that The FDA Group brought "extreme value" to the project by:
Successfully expanding the original scope to provide value across the Quality department.
Assisting in numerous additional areas without requiring extra headcount.
Achieving cost savings through efficient resource utilization.
Creating efficiencies that allowed for additional workload absorption.
Enabling a reduction in supplemental headcount.
Keeping budgets manageable throughout the project duration.
Building on this success, we’re currently engaged with the company on three additional quality system remediation projects in both the US and EU.
About our staff augmentation model
Staff augmentation offers a flexible solution for life science companies to access skilled professionals on a full-time contract basis. Teams can 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 QA, 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.