Engagement Models Staff Augmentation

Need rapid, flexible access to top talent? Fill staffing gaps with an individual or team of qualified resources. Our large staff provides broad capability and specific expertise through a convenient staff augmentation model for contracted full-time engagements.

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A convenient, flexible solution to life science resourcing.

Extend or augment your internal team with one or several skilled life science professionals through convenient full-time contracting. Our resources hit the ground running to immediately add value to your company through a contingent staff augmentation model perfectly suited for hiring needs that require full-time external support but don't justify hiring a permanent FTE.

We connect you to the skilled professionals you need to build, scale, and efficiently manage projects through a flexible contracted engagement that better reflects cyclical or project-based demand while infusing new skills and experiences into your team either on-site or remotely.

Tap into diverse competencies and skillsets for a predetermined or open-ended amount of time based on your evolving needs. With The FDA Group as your staff augmentation partner, you can easily increase or decrease your workforce as needs fluctuate—all while finding cost efficiencies in recruiting, screening, and onboarding staff. It's the smartest way to access talent in today's hyper-competitive specialized labor market.

All of our services are backed by a Total Quality Guarantee.

Scale your team as needs change.

Get rapid, flexible access to qualified consultants, contractors, and candidates in an increasingly competitive labor environment.

Fill in-house staffing gaps with perfect-fit talent.

We guarantee you’ll get the right resource, the first time.

Get world-class capability and expertise at a competitive rate.

Access our large, global staff of resources at a rate that fits your budget while avoiding extra payroll expenses.

Clearly defining Staff Augmentation

To be clear, staff augmentation in this context refers to the use of outside personnel on a temporary, full-time basis to augment the capacity of your organization. We colloquially refer to professionals resourced through this model as "full-time consultants" or "full-time contractors."

There are many scenarios in which companies leverage our staff augmentation model as an alternative or complement to traditional FTEs. These include:

  • Rapidly Increasing Capacity: Bringing on more specialized labor to fulfill a spike in work (such as project work, increased production, and or any other form of increased demand).
  • Bridge to Hire: For longer-term needs, staff augmentation is used as a bridge to provide capacity while hiring a permanent team. This use-case is common when staffing new facilities, turning up new lines of business, and in the lead-up to milestones in the product lifecycle that necessitate large hiring initiatives.
  • Accessing Specialized Skills: Staff augmentation is ideal for accessing niche out-of-house skills that are required for several months, but don't lend themselves to hiring an FTE.
  • Strategic Human Resourcing: Staff augmentation is also used to build teams using flexible labor as a way to gain a competitive advantage (via faster speed to market, greater agility, and the ability to "trial-run" and refine job descriptions). 

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Want to learn more about Staff Augmentation? Start here.

If you'd like a deeper dive into staff augmentation and how teams like yours are utilizing it to execute their projects on time and on budget, our expanded guide covers just about everything you need to know. It's the perfect starting point.

Read our staff augmentation guide »

FUNCTIONAL AREA Quality Assurance

Our quality and compliance specialists have extensive knowledge and experience in relevant regulations, guidance, and best practices related to quality system management throughout the regulated life science industries.

  • Fill in-house staffing gaps and scale your quality assurance function to meet changing demands.
  • Cost-effectively acquire the talent you need, where you need them.

We can fulfill contracted and direct hire resource placement needs in a variety of 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
  • Quality Management System (QMS) Specialist

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Functional Area Regulatory Affairs

We can assist your organization's regulatory staffing needs from the associate all the way through the senior level, covering virtually any specific skill set or expertise required. Our regulatory staffing capabilities range from an individual associate-level resource to a seasoned regulatory consultant with extensive experience leading or assisting with regulatory filings.

Our contracted and direct hire regulatory resources can fulfill functional needs and augment your team—providing access to experienced regulatory professionals that see projects through to success on time and on budget. 

Our regulatory resources provide expertise and capability in functional requirements including, but not limited to:

  • Leading or supporting FDA and global regulatory filings and health authority engagement
  • Augmenting internal staff and/or outsourcing key regulatory functions in any capacity
  • Leading or supporting developmental or approved product filings through CMC experience and expertise
  • Providing comprehensive technical knowledge and guidance into labeling and promotional activities
  • Managing all regulatory documentation as part of the start-up, conduct, and close-out phases
  • Ensuring submissions comply with regulations
  • Managing submissions and document storage processes
  • Staying abreast of all regulations to ensure documentation compliance

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Functional Area Clinical Operations

Demand for talented clinical operations professionals grows each day. How do you find the resource you need when you need them? Through years of connecting clinical operations experts with opportunities around the world, we’ve developed a large active and extended pool of talented professionals.

  • Fill in-house staffing gaps and scale your clinical operations to meet changing demands
  • Cost-effectively acquire the talent you need, where you need them
  • Work towards accurate and timely completion of your clinical trials
  • Cut down on administration, better control your overhead, and reduce turnover

We can fulfill clinical contracted and direct hire resource placement needs in a variety of roles and functions including, but not limited to:

  • Clinical Operations
  • Clinical Project Management
  • Clinical Monitoring
  • Biometrics & Data Management
  • Medical Writing

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FUNCTIONAL AREA Commissioning, Qualification & Validation

Power your commissioning, qualification, and validation operations with experienced life science resources. Fill internal gaps or target a specific role with an individual resource or team to see your project or program through to success. We provide you with support no matter which role you need to fill or which phase your project is in.

  • Fill in-house staffing gaps and scale your quality assurance function to meet changing demands.
  • Cost-effectively acquire the talent you need, where you need them.

We can fulfill contracted and direct hire resource placement needs in a variety of functions including, but not limited to:

  • Validation Master Plans (VMPs)

  • Design Qualification (DQ)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Equipment Validation

  • Software Validation

  • Process Validation

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FUNCTIONAL AREA Chemistry, Manufacturing, and Controls (CMC)

We help you achieve your next milestone by offering our expertise in all aspects of CMC development, including product, process and test method development, product stability testing, phase-appropriate validation, packaging development, and manufacturing and testing under GMP conditions.

  • CMC Strategy Development and Management
  • Drug Substance Process Development
  • Drug Product Formulation and Process Development
  • Analytical Development
  • CMC Regulatory Support
  • Biologics Development
  • Supply Chain Management
  • Quality Assurance and Control
  • Manufacturing Process Optimization and Technology Transfer

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Case Study Deviation Backlog Reduction, CAPA Management, and Long-Term Staff Augmentation

Learn how The FDA Group deployed its staff augmentation model to support a multinational pharmaceutical company's QMS remediation efforts. This project principally included deviation and CAPA backlog activities, significant corrective and preventive remediation throughout the quality system, and extended support to assist in staff onboarding, training, and maintaining the continuity of improvements made across the QMS. The FDA Group accomplished its goal of eliminating all backlogs on time and under budget.

Read the case study (PDF) »

Case Study Long-Term Quality System Staff Augmentation

Learn how The FDA Group partnered with a large clinical service company to manage its QMS remediation efforts and fulfill long-term staffing assignments for two vital roles in the management of the company’s quality and pharmacovigilance functions. This case study demonstrates the value of our convenient, cost-effective staff augmentation model as a means of circumventing the administrative costs and burdens of traditional hiring.

Read the case study (PDF) »

Why work with The FDA Group?

  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management For Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific resourcing needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.