Escape the audit trap

Leaders in pharma and biotech are drowning in meetings, batch record escalations, CAPA reviews, deviation boards, QA approvals, and cross-functional coordination. Time disappears into compliance-driven obligations, leaving little space for actual performance improvement. This edition explores why senior leaders feel constantly behind despite long hours. We break down structural time thieves in pharma- document backlogs, high review loads, endless data checks, and fragile processes. We show how stabilising daily operations through structured routines and data visibility frees leadership time for strategic decisions, not firefighting.

Jan 16, 2025

⏱️ 4 min read

Curated by Fabrice Gribon, founder and CEO of Gribon & Company. The CEO Shortlist - weekly briefing on the most actionable & tested ideas in operational excellence and business transformation for senior executives and leader of Change.

I'm writing this because I've seen too many brilliant pharma leaders, especially COOs and heads of operations, trapped in a relentless, compliance-driven cycle of firefighting. It leaves precious little room for actual performance improvement or strategic thinking. My main insight? Stabilising your daily operations isn't just about making things run smoother; it's about reclaiming your most valuable asset – leadership time – to drive real strategic change, not just endlessly audit the past.Setting the Stage

Setting the Stage

Walk into almost any pharma or biotech company today, and you'll find a common scene: dedicated leaders, working incredibly long hours, yet feeling constantly behind. They're drowning. Drowning in meetings, in batch record escalations, in CAPA reviews, deviation boards, QA approvals, and cross-functional coordination that feels less like collaboration and more like a never-ending game of whack-a-mole. In my experience, this isn't a sign of a lack of effort; it's a symptom of a deeper, systemic issue. The industry's stringent regulatory environment, while critical for patient safety, has inadvertently created a "time trap" for its operational leaders. It’s a trap where compliance-driven obligations consume nearly all available bandwidth, leaving little to no space for actual, proactive performance improvement.

The Current Challenge

What keeps these executives up at night? It’s the nagging feeling that despite all the effort, they’re just treading water. I’ve seen it firsthand: COOs who are brilliant strategic thinkers spend their days reviewing documents, chasing data, and mediating disputes that should never have reached their desk. The structural time thieves are everywhere. Think about the document backlogs that choke your systems, the high review loads that bottleneck every decision, the endless data checks required before anything can move forward, and the fragile, often manual, processes that break down at the slightest pressure.

These aren't just minor annoyances; they are fundamental drains on leadership capacity. When your day is dominated by firefighting — responding to the latest deviation, pushing a batch through a bottleneck, or preparing for an audit — you can’t possibly focus on building a more robust, efficient, or innovative operation for tomorrow. You're always auditing, always reacting, never truly improving. It’s an exhausting cycle that stifles innovation and prevents organisations from reaching their full potential.

The Vision for Change

Now, imagine a different scenario. Imagine if your daily operations were so stable, so predictable, that the vast majority of your team’s time wasn’t spent reacting to problems. Imagine if your leadership team wasn't constantly pulled into operational minutiae. What could you achieve then? The upside is enormous. Freeing leadership time from the compliance-driven firefighting allows you to pivot towards strategic decisions, market opportunities, and genuine performance uplift.

This isn't just about cutting costs; it’s about unlocking growth. It means more time for process optimisation, for talent development, for exploring new technologies, and for truly understanding customer needs. I believe this shift is the single biggest accelerator for change within any pharma organisation today. It allows you to move from a reactive, audit-heavy posture to a proactive, improvement-focused one. You'll gain agility, resilience, and a far more engaged workforce.

The Path Forward

So, how do you break free? It starts with a deliberate, hands-on approach to stabilising your daily operations. Here are a few practical steps you can implement today:

  1. Map and Standardise Critical Processes: You can't improve what you don't understand. Get your teams to meticulously map out your most problematic operational processes. Identify bottlenecks, rework loops, and non-value-added steps. Then, standardise them. Don't just document what you do; define the best way to do it and ensure everyone follows it.

  2. Implement Daily Management Systems (DMS): This isn't just another meeting. A well-designed DMS creates structured routines for frontline teams to monitor performance, identify deviations, and solve problems at the lowest possible level, before they escalate. This means visual boards, clear metrics, and short, focused daily huddles.

  3. Empower with Data Visibility: Stop hoarding data in silos. Give your teams real-time visibility into their performance metrics. When people can see the impact of their work and the problems immediately, they're empowered to act. This frees up leadership from being the sole source of information or problem-solving.

  4. Prioritise Problem Solving, Not Just Problem Reporting: Shift the culture from simply reporting issues to actively solving root causes. Invest in training your teams in structured problem-solving methodologies (like A3 or 8D). This is how you stop the same issues from recurring, finally breaking the firefighting cycle.

If you are serious about accelerating the pace of change within your organisation, you need to consider how much of your leadership bandwidth is currently consumed by operational noise. Reclaiming that time is your greatest opportunity.

If your operations, processes & team have not reached peak performance, I would be happy to chat through some ideas.

+447376132579

fabrice@gribonconsulting.com