Does Quality Begin with FDA Regulation?

Quality goes beyond the device, pharmaceutical or biologic produced and starts with…

Does Quality Begin with FDA Regulation?
In the life science industry, we put a high premium on ensuring the quality of medical devices, pharmaceuticals and biologics that are commercially available. The U.S. Food and Drug Administration and regulatory bodies in other geographies require adherence to Good Manufacturing Practices and a quality system that addresses the design, manufacture, packaging, labeling, storage, etc. of medical products that are for human use. A significant amount of effort is expended within life science companies to assure that our systems and products will be judged to comply with regulatory requirements. But does checking all the boxes and adhering to all the stated regulatory requirements yield quality?
Regulatory compliance is certainly necessary, but not sufficient, to yield quality. Quality goes beyond the device, pharmaceutical or biologic produced and starts with the quality of workers. With the many pressures for change, the characteristics required of the ideal employee will change as well.
Wordle Quality EmployeesResearch published this week by CareerBuilder and Economic Modeling Specialists, Intl. shows that 21% of companies surveyed have recently replaced some of their workers with automation, and 31% of the companies responding predict that certain jobs within their firms will be replaced by technology within the next decade. But that same research found that new technology has created jobs as well. Of the companies that replaced workers with automation, 68% indicated that the adoption of new technology resulted in the creation of new positions; 35% indicated the number of jobs that were created exceeded the number that was eliminated. Life science employers need to consider how they will prepare or compete for workers with the skills necessary to fulfill the knowledge-based jobs that new technology will create.
Forbes contributor Ken Sundheim suggests that companies will be best prepared for the future if they hire employees based on their personality traits rather than the factual information they possess. His logic is that information can always be taught, and that the information employees need to know will change over time. He suggests that the ideal employees – the kind that will assure quality even when regulatory requirements and technology change — will be:

Action-oriented Cultural fit Detail oriented
Intelligent Upbeat Modest
Ambitious Confident Hard working
Autonomous Successful Marketable
Display leadership Honest Passionate


How does your current workforce stack up on these attributes? Is your company well positioned to deliver quality in the face of change?
To learn more about how other life science companies have overcome hurdles and capacity issues to meet the challenges of change, contact us directly at 612.703.4236 or email to: Talencio, LLC is the preferred provider of vetted, accomplished professionals to the Life Sciences community.



31 Percent of Employers Predict Technology Will Replace Jobs at Their Firms. Mary Lorenz, August 4, 2014.

The Five Must-Have Qualities of a Modern Employee. Jacob Morgan for Forbes.

15 Traits Of The Ideal Employee. Ken Sundheim for Forbes.

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