When the QA Manager Leaves: A 5-Month Staff Augmentation Success Story
When a QA manager's sudden departure left critical systems in disarray, one experienced consultant stepped in to rebuild vendor management, implement new SOPs, and transform training programs.
As we move into the new year, Quality teams are finding themselves caught between the immovable object of a growing workload and the unstoppable force of budget cuts. This story is playing out across the industry as companies grapple with a perfect storm of layoffs, hiring freezes, and compliance demands.
Our latest case study offers a window into how Quality teams are adapting — and it's not through the traditional playbook of full-time hires and lengthy onboarding processes.
Instead, we're seeing the rise of staff augmentation: highly skilled contractors who parachute into Quality departments that are drowning in work and help them stabilize operations before things spiral into a serious situation.
This particular story centers on a virtual pharmaceutical company that faced several challenges when its QA manager unexpectedly left. The company, which manages both commercial products and development programs, needed to immediately maintain Quality oversight while operating with minimal internal staff.
Since settling in a few months ago, our consultant has:
Centralized vendor management with compliant qualification processes.
Strengthened Quality systems, including SOP revisions, eQMS management, and deviation handling.
Introduced GMP training programs and electronic training systems.
Ensured sustainable operations through knowledge transfer and onboarding support for new hires.
Improved compliance and streamlined Quality processes.
Stood up and trained staff on sustainable systems and processes left in place for long-term success.
If you need full-time or part-time contracted RA/QA/Clinical resources, don't hesitate to contact us. Given the regulatory challenges and budget constraints many teams are experiencing — 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
Following the unexpected departure of their Quality Manager, the company's Director of Quality turned to us to find a consultant we could embed to address a range of pressing challenges:
No centralized system for managing and qualifying vendors despite active supplier relationships
Incomplete SOPs across multiple Quality areas
Gaps in quality system documentation and processes
Limited training programs and resources
Intensive workload from Clinical and CMC groups requiring immediate attention
A need for enhanced coordination between operational teams
The FDA Group’s approach and solution
Our solution came in the form of a senior Quality consultant with over two decades of experience in pharmaceutical Quality systems. What made this approach different was its implementation: instead of providing advisory services, the consultant stepped into a full-time operational role.
The consultant's familiarity with the company's eQMS (Veeva) made an immediate impact. He began by establishing a structured approach to vendor management, creating centralized documentation systems and developing comprehensive qualification processes for suppliers.
Beyond vendor management, the work expanded to strengthen overall Quality operations. This included developing and revising SOPs, managing the electronic quality management system, conducting facility audits, and establishing effective deviation management processes.
Here’s a full list of just how much this consultant has accomplished on contract over just a few months:
Assessed state of quality systems using Veeva eQMS
Identified critical gaps requiring immediate attention
Created centralized documentation systems for supplier qualification
Developed comprehensive vendor evaluation questionnaires
Implemented audit schedules and procedures
Established FDA/EU-compliant processes
Built the company’s first centralized approved vendor list
Developed and revised SOPs to address documentation gaps
Managed the eQMS
Conducted facility audits
Coordinated Quality oversight with Clinical and CMC groups
Established deviation management processes
Implemented the first electronic training system
Created annual GMP training programs
Developed cross-functional team training materials
Established ongoing Quality education processes
Supported the recruitment/evaluation of permanent Quality staff
Created knowledge transfer documentation
Established maintainable processes for incoming personnel
Provided overlap support with new Quality team members
Here we see the often-overlooked advantage of bringing in a great consultant full-time: They don't just plug the immediate gaps — they build sustainable systems that continue delivering value long after they've moved on to their next project.
Results
The results to date have been comprehensive:
A compliant vendor management system with centralized documentation
Updated SOPs and quality documentation systems
New GMP training programs and electronic systems
Improved cross-functional team coordination
Standardized templates and procedures for ongoing operations
Again, we highlight these case studies because they reflect a larger shift away from the traditional staffing model and toward one that encourages more flexible approaches.
The movement of experienced Quality professionals into the consulting pool isn't just creating challenges; it's also providing companies with new options for maintaining Quality operations in a way that’s often cheaper, faster, and more agile than traditional hiring. Talk to us when you’re ready to start embracing this modern workforce model.
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.