Guest Column | October 11, 2016

6 Tips For Better Time Management In Pharmaceutical Operations

By Michael Esposito, TrainReach Consulting, LLC

6 Tips For Better Time Management In Pharmaceutical Operations

We all want to maximize the productive use of our time, correct? Over the span of my pharmaceutical industry career, I have been fascinated with this topic. It started when one of my supervisors in supply chain gave copies of The 7 Habits of Highly Effective People to me and the rest of his staff, which became one of many books on time management I have read. I have also been a keen observer of colleagues’ behavior and have analyzed the ways in which management has communicated its preferences regarding how employees spend their time. Any related piece of information piques my interest — for instance, I recall reading a book indicating that a supervisor held a stopwatch to time her employees' “bio breaks.” I hope this doesn’t describe your current reality!

Unfortunately, many of us live in a state of “work-life imbalance.” The balance we need between our work and personal lives is very elusive. What’s more, time management in the pharmaceutical industry carries with it some unique challenges. In the halls of pharma companies you hear the phrase over and over again, “We’re in a regulated industry.” The implication is that the regulated environment is a drag on our time, resources, and creativity. To be sure, regulations make us jump through hoops in ways that don’t apply to other industries. And regulatory agencies — as well as internal auditing groups — can sometimes act unpredictably and demand an immediate response, pushing their concerns to the top of your to-do list. We also complain about the complexity of our organizations and the lack of responsiveness of colleagues, and grouse about how hard it is to complete the simplest of tasks.

Regardless of the cause, employees often take work home with them. Some tasks cannot be completed at the office due to multiple interruptions, or because there is a hard-and-fast deadline that cannot be avoided, such as a regulatory submission or the launch of a new product. However, on many occasions I have noticed colleagues checking emails throughout the evening, apparently just in case someone may address a question to them, even when there was no specific activity looming. In one case, an employee was online every one of the 24 hours of a single day.

This type of anxiety will push pharma employees to act when it is not absolutely necessary, and to cut into their much-needed down time. Then, there’s the misconception that your boss and colleagues need to see you online in the evenings so that you appear to be giving more than 100% to the company. I can assure you through direct experience that this approach does not work. I have even heard employees being criticized for staying at work too late, leading to negative performance reviews!

Given this seemingly impossible situation, how can you manage your time effectively in our industry? Here are a few suggestions.

1. Balance self-discipline with flexibility. Lack of structure is often the reason why our time is wasted and bad practices creep into our work, so establishing a framework is key to our success. On the other hand, we also know that many events in our work and personal lives cannot be predicted, requiring us to adapt. I read an article about a painter who was born without arms (due to the side effects of his mother’s use of thalidomide) and learned to paint by holding the brush between his teeth or with his feet, depending on what he was painting. He indicated how his particular set of circumstances forced him to choose other options available to him. What most of us would see as an insurmountable obstacle became a great opportunity to adapt and succeed.

2. Prioritize your activities, set your schedule, and communicate these clearly and consistently.  In our industry, and particularly in supply chain, where I have spent my career, it is always helpful to use the "needs of the customer" approach to establish priorities. Summed up, I see it as providing quality product in a timely manner. Applied to my positions in GMP training, it means managing the training system so that employees can complete their training requirements through quality instruction and without undue delay. This overarching principle governs all of my scheduling decisions.

When organizing my time, I strive for a balance between work at my desk and short, effective meetings — this keeps me from getting bogged down in either type of activity. It also makes sense on a personal level, as I am more effective when I work in short spurts, interrupted by brief breaks or changes in focus. I also make sure to allow enough time to collect and report metrics, which in our industry have become more important. I don't consider metrics a waste of my time, as long as the ones I'm reporting pass the "needs of the consumer" test. In GMP training, I did not have control over which ones management required, but to those I added metrics that my training software could generate automatically and that were significant to me, even if I didn't need to report them.

For the evenings, I give my colleagues my cell phone number and explain that they are free to call me when they have a need that can’t wait until the next business day, but I don’t go looking for communication during off-hours. In the long run, show people that you are responsive to their needs while taking care of your personal life (more on this in a moment), so that you can perform at a high level consistently over time.

3. Learn how to say “no” without appearing uncooperative. My goal has always been to provide exemplary service to the people who depend on me during the work day. Still, over my career, I’ve gone from saying “yes” all the time to adding “no” when appropriate. I have learned to say something like, “I’m sorry, I have to finish this, but as soon as I’m done I’ll get back to you.” To be sure, there are times when you absolutely cannot say "yes" to certain requests, but often you can meet someone halfway, a quarter of the way, or wherever the situation requires. Time has taught me that it’s best to be up front with people, though there are diplomatic ways to communicate your situation. Again, use the "needs of the consumer" rule to help determine your priorities when you are asked to do something unexpected.

4. Embrace the rigors of a regulated environment. The pharmaceutical industry’s regulated environment can impose a discipline that in the long run will benefit you and your colleagues. An inadequate quality infrastructure is often behind the most egregious deviations from Good Manufacturing Practices (GMPs), which can lead to fines, reduced consumer confidence, lower sales, and more importantly, harm to our consumers. Resist the temptation to bypass established procedures, in particular quality assurance oversight, to gain a short amount of cycle time to get product to market — in spite of the pressure you may feel to move faster than is feasible. A well-defined process that builds quality into its design will save time and money in the long run. If you need to make changes to your process, the heat of the moment is not the time to do so. Also, remember that too many planned deviations raise red flags with regulators.

5. Be an advocate for process improvements. Another time management strategy is educating your colleagues to strike a balance when it comes to adding steps to manufacturing and quality processes. There will be times when the organization won’t allow you to influence these processes and act accordingly. However, if you work in an environment where your views are heard and your colleagues give your ideas a chance to succeed, try to have your team members reject the notion that more is necessarily better — and offer viable alternatives. One relevant example relates to establishing procedures for developing, reviewing, and approving standard operating procedures (SOPs) and other GMP documents within the organization. If the process is too cumbersome, necessary improvements to SOPs cannot cycle through the system in an efficient manner, and opportunities to improve quality and efficiency can be lost.

6. Don’t shortchange your family — or yourself. The ability to disengage from work and spend time with family, with friends, or on your own is your right (and need) as a human being. There are emergencies, of course, but when the emergency becomes routine, examine what is prompting them: your own choices, unreasonable expectations by others, or some unavoidable external factor. There is never a time when choosing work over family as a pattern will, in the long run, help you or those around you. Think about it: Aren't you more prone to making mistakes that could cost your company dearly (483s, warning letters, backorder situations, recalls, etc.) if your work-life balance is out of kilter and you are fatigued and/or distracted at work? 


It all boils down to this: You have to be the master of your own schedule. Your supervisor will have priorities that you will have to follow, but you need to use your own brain and determine exactly how much power you have to influence your circumstances. Remember the general rule of focusing on the needs of the customer to balance quality and timeliness — as well as the consequences of both poor quality and inefficiency — and advocate for these in your organization. Often, we have more control over our environment than we think!

About The Author

Michael Esposito has 30 years’ experience in the pharmaceutical industry and 13 years’ experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas, including packaging, project administration, quality assurance, government contracts, translations, systems training, and international operations. He collaborated on the development and implementation of the training portion of the consent decree work plan for McNeil and revised their introductory GMP course. Michael is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging. You can reach him at