Leading the Turnaround Quality Control Lessons from the Field

In sterile pharmaceutical manufacturing, Quality Control (QC) is often expected to serve as the backbone of product quality.

However, too often, QC departments find themselves stuck—overwhelmed, under-resourced or misaligned. I have been called into these situations more times than I can count, and the story is usually the same: good people working hard in a system that is failing them.

Rebuilding QC is not about buzzwords or quick wins. It is about getting back to fundamentals: people, process and purpose. Below are the hard-earned lessons I have learned helping QC teams turn things around when the stakes are high.

Stabilize: You cannot fix a process that is in chaos. Before chasing metrics or digital tools, stabilize the basics. Get sample flow under control, organize documentation, train and qualify staff, and eliminate low-value work. Too often, teams are buried under tasks that do not move the needle. Take a hard look at how time is spent. Clean up first, then build forward.

Alignment: Your organization’s chart does not matter if your team is not set up to succeed. You need leaders who can lead, not just manage. You need analysts who are trained, empowered and clear on expectations. Sometimes, that means reshuffling roles and other times; it means having tough conversations. But if you do not get the right people in the right seats, you will keep spinning your wheels.

Focus: QC departments are often overwhelmed, not because the workload is unmanageable, but because the priorities are unclear. In a resource-constrained environment, everything cannot be a priority. Leaders must ask: Which activities add value? Which are required for compliance? Which can be automated, delegated or eliminated? Focusing your team on high-impact work such as deviations, release testing and critical method performance creates space for continuous improvement.

Engagement: QC does not work in a vacuum. Your internal customers, manufacturing, Quality Assurance QA, Validation and Manufacturing Sciences and Technology (MSAT) depend on QC to meet timelines, resolve issues and ensure product quality. Effective QC leaders understand these relationships. They engage regularly with stakeholders, clarify expectations and proactively collaborate on investigations and process improvements. Knowing your customer changes how you manage your team and how your team delivers results.

Investigation: Deviation management is a window into your department’s health. If root causes are superficial, repetitive or vague, that is a symptom of poor investigation culture. Robust deviation handling is not just a compliance requirement but an opportunity to drive continuous improvement. It requires real-time problem identification, cross-functional input, data-driven root cause analysis and effective CAPAs tied to process risk. QC should never just "close" deviations. It should learn from them.

Measurement: Metrics are useful until they are not. Many teams get buried in dashboards that do not drive decisions. Start by asking, "What are we trying to learn or change?" Then, build metrics around that. Some may be standard, like OOS rates and deviation aging, but others should reflect your site’s unique risks and goals. If your metrics are not helping you lead better, they are just noise.

Development: One of the best things a site director ever said was, “I want people leaving skid marks on the way to work, not on the way out.” That stuck with me. Because when people feel invested in, they invest back. Train your analysts. Show them advancement opportunities. Recognize their wins. The lab is not just where testing happens; it is where culture is built.

Efficiency: A lot of QC processes were built years ago and never questioned. That is how you end up with forms no one reads, checks no one uses and workflows that waste hours. Rebuilding means challenging the status quo. What adds value? What protects patients or compliance? What is just legacy noise? Be willing to let go of what does not serve you anymore.

Advocate: When pressure hits, it is easy to let your team take the heat. Do not. Your job as a leader is to shield your people from politics and blame while holding the line on quality. Advocate for realistic timelines. Speak up when the lab is under-resourced. Fix broken processes instead of pointing fingers. When your team knows you have got their back, they will give you everything they have got.

Conclusion

A strong QC team does not happen by accident. It takes clarity, courage and commitment. If your department is stuck, do not look for silver bullets, look at the basics: stabilize the process, get the right people in place, focus on what matters, build relationships, investigate thoroughly, measure wisely, empower your team, and stand up when it counts. Because quality is not just something you test for, it is something you build.