Supervisors Need Not Apply

July 30, 2004
Manufacturing's Shift from Blind Compliance to Continuous Improvement Requires New Leadership

Change is never easy, and if one's long been conditioned that the road already traveled is the best, that proven beats novel, that stable trumps responsive--change can be especially disorienting if not downright terrifying.

Yet that is precisely where the pharmaceutical manufacturing industry finds itself today. Fat profit margins that once insulated manufacturing operations from self-examination and continuous improvement have all but evaporated. Management, whose edict to manufacturing was once "spend what you need to, just don't get us in trouble!" is now pushing manufacturing operations to become leaner and more efficient.

Meanwhile, the FDA is pushing drugmakers to improve their understanding and control of manufacturing processes, to embrace continuous improvement methodologies that will bring high-quality drugs to market more efficiently, more quickly and more cost-effectively.

Bottom line, pharmaceutical manufacturing is in a perfect storm of forces for change. And reluctant acceptance isn't enough; continuous improvement means that change must be embraced, indeed pursued. The shift in mindset is foundational, affecting how organizations are structured as well as what skills will be most in demand in the future.

Take this month's cover story on Novartis. Its push to go lean led the company to eliminate the traditional supervisor function at its Suffern, N.Y., plant, restructuring around product-oriented teams coordinated by team leaders. For example, eighty people across functional disciplines work on the Diovan team, all reporting to team leader Brian Hanifin.

Managing eighty direct reports is difficult to imagine, until one realizes that traditional "supervisor" functions have been pushed down to peer-review level, leaving the team leader with more time to, well, lead.

Some former supervisors didn't adjust to the change and left the company, says Tom Van Laar, vice president of pharmaceutical operations at the facility. But for others it was liberating: "'All of a sudden, I'm not leaning on people and they're getting things done,'" said one supervisor-turned-team-leader. "That's the kind of cultural change we're aiming for," says Van Laar.

Word selection here is very important, and reflects the new reality of pharmaceutical manufacturing. "Supervise" connotes a top-down, hierarchical view of the world that is very well suited to the blind compliance traditionally required of drugmaking: Go through the exact same validated motions on every batch, and we won't get in trouble with the FDA.

But, layer continuous improvement onto the compliance equation and you're asking for a new set of leadership skills. Not the leadership of extroverted banter or stirring speeches, but of vision and communication, of intellectual rigor and bias to action, of accessibility and honesty, of attitude and integrity.

Technical chops and attention to detail are now but the cost of entry. Look to the pages of Pharmaceutical Manufacturing over the coming months as we expand our coverage of the softer skills you'll need to take your career, your company, our industry, to its next level.