Industry Solutions
Life Sciences Contingent Workforce Solutions
Contract labor programs built around GxP obligations, validated systems, and inspection evidence, not retrofitted from a general-industry template.
Viltis builds life sciences contingent workforce solutions for organizations where a contractor's training record matters as much as their bill rate. In pharmaceutical, biotechnology, medical device, and diagnostics environments, non-employees routinely touch batch records, validation protocols, clinical data, complaint files, and quality systems. That places them inside the same regulatory scope as your employees, while your program controls, supplier contracts, and reporting were probably built for general staffing. We close that gap by designing the workforce program around the regulated work itself.
Overview
Why general-industry programs break in regulated environments
A standard contingent workforce program optimizes for cost per hour and time to fill. Those metrics still matter here, but they are not sufficient. If a validation engineer completes an assignment and the training records supporting their work cannot be produced two years later, the savings on the rate card are irrelevant.
The failure modes are consistent across companies we speak with: contractors granted quality system access before training completion, classification decisions made by hiring managers without legal review, supplier contracts that never contemplated data integrity obligations, and no reliable list of which non-employees are currently qualified to perform GxP-impacting work.
Overview
Roles these programs typically cover
The scope follows where regulated organizations really flex capacity: submissions, inspections, tech transfers, clinical milestones, and remediation commitments.
Quality assurance, quality control, and GxP auditing personnel
Regulatory affairs specialists, submission publishers, and regulatory operations staff
Clinical research associates, clinical data managers, and study startup specialists
Validation, CQV, and computer system validation engineers
Manufacturing sciences, technical transfer, and process engineering support
Pharmacovigilance case processors, safety physicians, and signal management staff
Complaint handling, post-market surveillance, and CAPA remediation resources
Overview
Program controls that map to regulatory expectations
We build the control set with your quality and legal teams instead of importing one. What that buys you is a workforce program already holding evidence for the questions an inspector or auditor will ask about non-employee personnel.
Documented qualification: role-based training assignment, completion tracking, and retention after assignment close
Access governance: system provisioning tied to training status and deprovisioning tied to assignment end date
Worker classification reviewed against policy before onboarding rather than during an audit
Supplier agreements that carry data integrity, confidentiality, and record retention obligations down the chain
Assignment tenure and conversion policies applied consistently instead of case by case
Overview
Demand that does not follow a headcount plan
Regulated programs surge for reasons a workforce plan cannot anticipate a year in advance. A Form 483 observation, an unexpected inspection, a clinical hold, a supplier quality escalation, or an accelerated submission all create immediate demand for qualified people who can work inside your quality system.
A managed program shortens that response because the supplier base, rate structure, onboarding path, and approval chain are already agreed. The conversation becomes about which qualified candidate, not about how to contract for one.
Overview
Four industry segments, four different problems
The regulatory frame differs enough by segment that we treat them separately. Pharmaceutical programs revolve around GMP manufacturing and submission cycles. Biotech programs are shaped by funding milestones and thin internal infrastructure. Medical device programs live inside design controls and EU MDR obligations. Diagnostics programs balance IVDR, laboratory operations, and CLIA-regulated environments.
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Related capabilities
Pharmaceutical
GMP manufacturing, submission cycles, and commercial-scale quality operations.
ExploreBiotechnology
Milestone-driven growth, lean infrastructure, and first-time program build-outs.
ExploreMedical Device
Design controls, EU MDR remediation, and post-market surveillance capacity.
ExploreDiagnostics
IVDR transition, laboratory operations, and assay development resourcing.
ExploreBenefits
What a life sciences program delivers
Qualified before productive
Onboarding sequences training, qualification, and system access in the right order, so contractors are not performing GxP-impacting work ahead of documented readiness.
Evidence that outlives the assignment
Screening, training, and access records are retained against each assignment after it ends, which is when inspection and audit requests usually arrive.
Suppliers who understand the environment
Supplier qualification weighs regulated-industry delivery, not just headcount capacity, so submittals reflect people who have worked inside quality systems before.
Surge capacity without side deals
When a 483 response, inspection, or submission deadline compresses the schedule, capacity is added through the existing program rather than through emergency contracts.
Classification handled by policy
Worker classification and co-employment posture are set with legal and HR up front, which takes those decisions out of the deadline scramble.
One picture of the non-employee population
Leadership can see how many non-employees are engaged, in which functions, at what cost, and with what qualification status, in one report instead of five.
FAQ
Life sciences contingent workforce FAQs
Can contract workers perform GxP-impacting work?
Yes, and they routinely do. The obligation is that they are trained, qualified, and documented to the same standard as employees performing equivalent work, and that the evidence is retained. The workforce program is what makes that consistent instead of leaving it to individual hiring managers.
How do you handle training records for contractors?
Role-based training requirements are assigned at onboarding, completion is tracked before system access is granted, and the records are retained against the assignment after it closes. Where your learning management system is the system of record, the program reads status from it instead of keeping a second copy.
What happens to system access when an assignment ends?
Deprovisioning is triggered by the assignment end date held in the vendor management system, and the program reports on access that remains open past that date. Orphaned quality system accounts are one of the most common findings we see in unmanaged environments.
Do you cover statement of work consultants as well as hourly contractors?
Yes. Consulting and SOW engagements often carry the same regulatory exposure as staff augmentation while sitting entirely outside workforce reporting. Bringing them into scope is a standard part of the program design.
Can you support a program that spans multiple sites or countries?
Yes, though multi-country programs require attention to local employment law, works council consultation, and data residency before rollout. We phase those programs by country or region rather than switching on globally.
Does Viltis supply the contractors as well as manage the program?
We can, and we also run vendor-neutral programs where Viltis manages the process and other suppliers compete for the work. The model is agreed up front so that program governance and supplier performance measurement stay credible.
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Industry programs and related capabilities
Ready to talk through your program?
Bring us your current spend, supplier list, and compliance obligations. We will show you what a technology-enabled contingent workforce program would look like for your organization.