Have you assessed the strategic risk of your company’s readiness to meet the following regulation in the future?
“Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions (21 CFR 211.25(a))”
Or are you relying on HR hiring practices and outdated job descriptions to manage this risk for you?
The Global Science, Technology, Engineering, Mathematics (STEM) Dilemma
The next workforce shortage will not be caused only by a lack of graduates in the correct disciplines – it will also be caused by employers failing to keep their existing workforce current with the appropriate training. Having meaningful conversations about the current skills of the workforce without mentioning the impact of AI is a challenge. Technology is speeding past the ability of staff to implement it, especially in a regulated environment. This is exemplified by a report in the World Economic Forum (4. Workforce strategies – The Future of Jobs Report 2025 | World Economic Forum) which states worldwide that half of surveyed executives (11,000) highlight a lack of skills to support adoption as the top barrier for AI adoption. Just as alarming is the identified risk (43% surveyed) that cites a lack of vision among managers and leaders. Their views on this global pool of talent is important since this sets the stage for not only personnel in pharma/biopharmaceutical industry, but also the availability of a workforce with transferrable skills.
The Life Science Ecosystem Reality
A study published by Manpower (Talent Gap in AI: Life Sciences & Medtech Must Adapt) states in a Life Science Hiring Trend, “57.8% of all tracked roles are completely new.” In the same report, the demand for skills in AI compliance, validation, and regulatory affairs is reported to be undergoing significant growth but experiencing a skills shortage. So just what are the new roles and skills needed to not just compete, but to stay relevant? According to a study by IntuitionLabs (Pharma’s AI Skills Gap: A 2025 Data-Driven Analysis), the size of the AI adoption prize is, “… $250 billion in value over five years. Yet this promise hinges on having people who can build, deploy, and govern these AI systems”. In our industry, it cannot be overstated that skills in AI for QA, RA, and Governance professionals is at a critical tipping point. In the short term, pharma/biopharma companies may need to resurrect the legacy business analyst (BA) role frequently used in the 1990’s and early 2000’s to translate business requirements into technical requirements as an intermediate control.
Step Zero: Become Aware of YOUR Situation
Companies are well advised to deploy effective governance policies that integrate risk management, talent management, and culture. Industry leaders are now actively engaging experienced consultants, such as Lachman, to provide a global and independent view of their organizational readiness in adopting new technologies (including AI) and to manage technology adoption as a QRM associated strategic risk. A good plan starts with a clear and unbiased view. What is your view of your own organization?
