US Quality

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Anonymous

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The left over quality leadership scraps of Burton, Boselli, and aweful Mattei are absolutely useless. They are not listening to the tunes MP is singing. They are next in line to get fired. Watch out.
 












Having recently left a quality role and served with these fine men, I can say you're wrong. They kept B&L's nuts out of the fire with FDA on numerous occasions and helped build a quality culture that was among the best I've seen in a med device, pharma company. I predict that as the culture they helped build loses people and focus, quality problems will again arise and FDA will be slapping 483s or worse on B&L. It's just a matter of time. I know FDA is already very concerned with the loss if key individuals at the corp and plant levels. Valeant's gonna regret destroying B&Ls QA and RA depts.
 






Boselli and Burton well meaning but work so slowly that the business gets hurt whilst we await their decisions...Mattei....causes so much damage to the business by dumb ignorance and dictatorial behaviour...
He will fit Valeant well as they both are trying hard to destroy B+L
I wish Mattei on Valeant...they deserve each other.
 












Anonymous said:
Impressive. Good to know there are others out there finally recognizing the massive millstone around our necks that Quality has become.
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There's a bunch of us out here in California heard rumors in the past several months this is what's keeping St. Louis from getting new products on the market. We all kind of dismissed it. Maybe there was something to it.
 






California is a goner for sure. Quality people this us a fact, by Q2-2014, 105 QA people will be fired in US sites, R &D and supplier quality. You can move on now with your head up and find a job ASAP (market is very desirable) or get fired later, you will be much better off now.
Good luck
 






The QA group in Rochester is done. Boselli, Burton are goners in Q-1. Funny thing is they think they are VPs - not even worth crap, Valeant will fix that as they re-assess the new bonus structure and organization. With this many VPs and no global businesses how can BL justify carry all these VPs - haha
 






Anonymous said:
The QA group in Rochester is done. Boselli, Burton are goners in Q-1. Funny thing is they think they are VPs - not even worth crap, Valeant will fix that as they re-assess the new bonus structure and organization. With this many VPs and no global businesses how can BL justify carry all these VPs - haha
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Someone sounds a bit envious. What, your career not living up to your expectations? Maybe you're not as great as you think you are
 


















Valeant philosophy is to make money not protect against the regulators. Their Eastern European sites on the average receive 12-15 non conformances and they believe that is very normal. Their mindset tells them that it is ok not to comply to regulations but they must make money. US watch out
 






Anonymous said:
Someone sounds a bit envious. What, your career not living up to your expectations? Maybe you're not as great as you think you are
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Where is this even coming from? This comment is irrelevant to the topic. You might have as well typed, "Mushroom television yellow walnut" and it would have been as meaningful. In my 20+ years @ B&L, I've never seen anyone envious of a Quality position. Most people make fun of the fact they have become mindless non-thinking, unable to problem solve drones and stumble around bumping into walls and spewing, " FDA !! FDA!!" if anyone asks them to justify their perpetual illogic.
 






Anonymous said:
That will b fun to watch. Start a pool on recalls, warning letters, and findings for 2014.
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Herein lies the problem with Quality @ B&L to date. Recalls, warning letters, and findings do not necessarily a crisis make. Sometimes, these events merely occur over the course of doing business and are a simple fact of life. What B&L never did a good job of asking itself was, "how much is this level of quality costing us?" Quality is overhead plain and simple, it is not a profit center. A smart corporate structure will recognize quality for what it is, and manage it accordingly.
 






Anonymous said:
Valeant philosophy is to make money not protect against the regulators. Their Eastern European sites on the average receive 12-15 non conformances and they believe that is very normal. Their mindset tells them that it is ok not to comply to regulations but they must make money. US watch out
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And you know what .....???? there's nothing wrong with this. If it's part of the business model, so be it. You really need to think about this from an accounting / finance perspective. You can beef up the ranks with a boatload of indirect overhead of offices and cubicles of staff, and directors, and assistants, and VPs with salaries, and insurance, and vacations, and other benefits that may or may not make things easier for 5 - 10 people during an audit. Or, you take the gamble, that most of the time you can trust most of your people to be doing the right thing and a few times a year, during various audits, your quality people actually have to get up off their chairs, leave their offices, come into work on time, not take 2 hour lunches, and get up and walk around and interact with other people, the LGA, the FDA, etc and you know, do the things they get paid for. And God forbid, there is a finding, or a warning, or whatever it's documented, addressed, and corrected, and life moves on.
 






Anonymous said:
By the way Valeant will love the new trimmed structure of BL quality and will make Quality report to plants - so QA is out, get ready you under achievers.
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There's a lot of us that hope you're right. Quality desperately needs to report at the plant level so that your operations groups can regain the control of the bottom line that they forfeited some years ago when the reins of the plant day to day operations were turned over to quality essentially transforming the manufacturing facilities into a police state operating in complete fear of an audit or anything that might resemble one - instead of the quality organization accepting its natural role as a support operation.
 






Anonymous said:
Having recently left a quality role and served with these fine men, I can say you're wrong. They kept B&L's nuts out of the fire with FDA on numerous occasions and helped build a quality culture that was among the best I've seen in a med device, pharma company. I predict that as the culture they helped build loses people and focus, quality problems will again arise and FDA will be slapping 483s or worse on B&L. It's just a matter of time. I know FDA is already very concerned with the loss if key individuals at the corp and plant levels. Valeant's gonna regret destroying B&Ls QA and RA depts.
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Ahh yes, spoken just like a useless director or VP who hasn't stepped foot on a manufacturing floor or knows anything about the manufacturing process improvements made in the past 5 years.
 






Anonymous said:
Where is this even coming from? This comment is irrelevant to the topic. You might have as well typed, "Mushroom television yellow walnut" and it would have been as meaningful. In my 20+ years @ B&L, I've never seen anyone envious of a Quality position. Most people make fun of the fact they have become mindless non-thinking, unable to problem solve drones and stumble around bumping into walls and spewing, " FDA !! FDA!!" if anyone asks them to justify their perpetual illogic.
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Oh my goodness, so this happens in your plant too? In ours, I'm pretty sure these are the only 3 letters of the alphabet that anyone in the quality organization knows. Any doubt, or question, or challenge is immediately met with: FDA !! FDA !! FDA !! It's like some prerecorded message they're all indoctrinated to utter at the slightest inclination of uncertainty.
 






Just telling you MP is removing 45% of US QA org by Q3-2014, he wants leaner than lean org similar to his European plants, he only cares about the bottom line and that is $. Global
Org's drain money and QA is one of the key contributors to this drain. Rochester global QA, US supplier QA and US design QA groups are in process of being scheduled to be reduced to bare minimum if any - it is a done deal trust me. Move on people or you will find yourselves to blame.
 












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