Stability Career Situation
All Situation Room examples are constructed and not descriptions of actual events.
Published on: August 10, 2024
Walter Routh
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What is the stability situation?
I have been managing a quality lab for nearly 8 years in a large fortune 500 pharmaceutical company. In addition to quality release testing and some R&D work, my labs have been responsible for stability testing and some result trending. Over the years I’ve found that although stability testing only involves 30% of our testing volume it takes up over 50% of my management time. We have upper management breathing down our necks for high-risk studies, we have high impact OOS investigations that could lead to recalls and we have out of trend results that cause all fingers to point to my analysts.
Recently the stability manager announced her plans to retire and my director is asking me to consider making the move to manage the full stability program, including chambers with over 1000 active studies, a staff of 15 people and annual reports, filings and a million prying eyes. I’m worried about my work life balance, with my wife and three younger children and me essentially being on call 24/7 even while on vacation, at school functions or on a date night. I’m also aware, though, that the work is rewarding with direct impact on patient safety and high visibility for future advancement.
What are some of the aspects of the Career blog article by John O’Neill (Aug 2024 SH Newsletter) that I could use to help make this difficult career decision?
How should this be resolved?
Find a guru – some highly experienced Stabilitarians, or even one of the 15 current stability staff with significant experience – to help you understand the career pros and cons vs. the personal pros and cons.
Get to know the Territory – Request process maps and a list of stability stakeholders so you can learn about the stability environment more in depth and not be surprised after your decision is made.
Network within – As part of an informational tour, tap into some of the more than 30 stakeholders in the stability process. Meet with several of them to learn their opinions of the current stability program, their suggestions and from there, determine if you’re the right fit to help bring about improvements needed or if your family life may suffer.
What other thoughts and advice do people have for this potential Stabilitarian?
We Want to Hear Your Thoughts!
March 30, 2025
When it comes to filings we expect no surprises from stability data. One company found aberrant data like a rude April Fool’s joke, so what process can they implement to eliminate these surprises?
March 2, 2025
Your Honor, where do we turn if money is not available to purchase stability chambers and alternative storage options are not readily available? Budget timing and quality roadblocks are putting stability chamber space in danger of overflowing.
February 7, 2025
Upper management has a dangerously low awareness and vigilance of stability. They haven’t had a significant event or audit observation to raise alarms and put us at top of mind. As a result, we get the dregs of personnel and budget—this needs to change.
Share your questions and experiences
A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
