Organizational change can take on many guises. Most changes are planned and orchestrated by company management (such as a plant expansion, an updated MRP system or a new incentive program). However, some of the most impactful changes are nearly impossible to predict.
Tectonic shifts such as Brexit leave lasting changes that play out over a long time. Changes can also result from a public health crisis (such as Heparin contamination and counterfeit Avastin). Adapting an operation to meet new regulatory requirements can be extremely demanding and costly, as with the work underway to implement serialization and the European Medicines Verification Organisation repositories. And unfortunately, some changes may result from a problem of our own making. For instance, a regulatory warning letter is usually preceded by a series of poor GMP inspections that point to reoccurring and often avoidable issues. Resolution of these issues will undoubtedly require significant changes to company quality systems and, in many cases, even larger changes to the company quality culture.
In all of these situations, change, regardless of its origins, always spells opportunity. What results is often an opportunity to improve what you do and what your company does. However, there are differences in the execution that will ultimately have an impact on how well a company, plant site or unit operation embraces change.
Let’s examine three types of change and considerations for navigating each type.
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Jim Morris has over 25 years of pharmaceutical management experience in both plant operations and corporate offices, working with Pfizer, Cilag AG and Mass Biologics in the U.S. and Europe. He has held positions as Deputy Director QA/QC and Regulatory Affairs while at Mass Biologics, Director of QA/QC for the Biologics business unit of Cilag AG and a number of quality assurance and manufacturing roles with Pfizer over a 16-year timeframe, culminating as the head of Quality Assurance for Pfizer in Latina, Italy.