Contractor or Consultant?
As with most high-tech industries, the healthcare industry must be able to react to an ever changing environment. It would be ideal if businesses could have a contingent workforce of resources available when needed, but that is not financially feasible for any business. The use of a temporary workforce seems to be the wave of the future to address these short–term resource needs. There are a several factors to consider following the decision to hire an outside resource. A few questions are;
- Contract or Consultant? What’s the difference?
- Experience – what technical skills are needed, does the resource need certification?
- Supplier/Source – Do we have an approved supplier for these service
- Costs – How will we be charged, hourly, project deliverable?
- Communication – who will be our point of contact for any issues/updates?
|The Industry must have the ability to quickly ramp up its technical resources. This may be the result of a critical project, compliance issues, or an unexpected loss of resource(s). This can be challenging when faced with recruiting, hiring, and training which can take months while the project is delayed or there is compliance /business risk.|
The first question often asked is what is the difference between a Consultant and a Contractor?
A Consultant is an experienced professional which provides expert technical knowledge in return for a fee. Typically this is an advisory role only. Consultants bring knowledge into the business which can redirect the management team into new ways of thinking to address issues and improve performance of the organization. Consultants can command a high fee due to their years of experience and are viewed as being some of the most knowledgeable people in their chosen field
A contractor is an experienced professional, but provides a specialized service in return for a fee. Unlike a consultant, a contractor will actually carry out physical work. Contractors are used by organizations that wish to acquire a given skill set for a period of time, but which do not want to employ someone permanently. As such, a ‘contract’ is usually full time but for a set period.
What services are needed? It is important that the resource has the scope of experience and technical skills to meet your needs. For example;
- Validation – Software, Equipment, Process, Material, Sterility, etc.
- Auditing – ISO 13485, ISO 15189, QSR 820, 210, 211,
- Regulatory Submissions – 510K or PMA, Pre-amendment justification/support, IND, NDA, BLA
- Quality Systems – Design Manual, Risk Assessment, DHF, Product/Process controls, CAPA, Complaints, Recalls, Document Control
There are a lot of firms who offer specialized services. Key questions which should be considered are; is the supplier qualified under your QS requirements? If not, can they easily be qualified based upon the organizations Quality System? What specialized services do they have? Does the supplier have characteristics which will meet internal sourcing goals? i.e., veteran-owned, woman-owned?
Safis Solutions is considered a boutique consulting firm with expertise in Regulatory Consulting and Submission, Quality System Design Consulting, Computer System Validation, and Supplier Auditing for Pharmaceutical, Medical Device, and Biotechnology industries.
|Safis Solutions, LLC is a firm which provides both consultant and contract resources. We specialize in areas of regulatory compliance for both the U.S. and Outside U.S. markets.|