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03.20.25 47 min read

#050: Operational Excellence in Pharma: Why the Industry Lags and How to Catch Up

#050: Operational Excellence in Pharma: Why the Industry Lags and How to Catch Up

Pharma has long been a laggard in operational excellence; it now has every reason to become a leader. The companies that seize this moment – shedding the old excuses, transforming their culture, and relentlessly focusing on efficient, quality-centric operations – will not only outperform their peers, they will better serve patients and ensure their own relevance in a rapidly evolving healthcare landscape. The prescription for pharma’s operational woes is in hand – now it’s time to take the dose and act.

 
 

 

1.0 Introduction: Pharma’s Operational Excellence Gap

Pharmaceutical manufacturing is often called out for inefficiency and slow improvement. Despite being a high-tech industry in research, its production operations have notoriously lagged behind other sectors in productivity and innovation. For decades, drug makers enjoyed high margins and stable demand, which removed urgency to optimize plants. But times have changed – cost pressures, global competition, and rapid advances in digital and automation demand that pharma elevate its operational game. Yet progress remains slow.

Why does a highly regulated industry like pharma struggle to achieve the operational excellence seen in other equally regulated fields? This analysis examines the common excuses and deeper causes – from over-reliance on “compliance” to leadership blind spots and the quality assurance (QA) bottleneck – that have held pharma back. We also compare pharma’s performance to industries that have thrived under heavy regulation, and recommend how pharma can finally boost productivity, drive innovation, eliminate waste, and engage employees to close the gap.

 

2.0 The Compliance Excuse: Blaming Regulation for Inefficiency

Ask pharma insiders why their processes are inefficient or slow to improve, and a common refrain is, “We’re heavily regulated – we can’t change easily.” It’s true that drug manufacturing operates under strict good manufacturing practices (GMP) and intense oversight to ensure patient safety. Documentation is enormous – roughly 30% of staff time is spent on record-keeping, with a single biotech batch record requiring thousands of manual entries. Any process change may require re-validation and regulatory approval, adding bureaucracy and delay.

However, using regulation as a blanket excuse for poor operations doesn’t hold up to scrutiny. Industry experts note that many modern production methods have been around for decades and widely adopted elsewhere, yet pharma has been extremely slow to embrace them – “in ‘Pharma Time’, it normally takes 40–50 years to implement a new technology,” and “one cannot always blame regulatory bodies” for this glacial pace. In fact, FDA officials have repeatedly signaled support for innovation. As early as 2010, the FDA stated there were “no regulatory hurdles” to adopting continuous manufacturing – a cutting-edge technique to improve efficiency. FDA leaders have even acknowledged that drug factories today look familiar to experts from the 1950s (i.e. very little has changed), and challenged the industry to modernize within 25 years. Clearly, regulation alone isn’t what’s keeping pharma stuck in the past – perceived regulatory barriers often loom larger than actual ones.

Other highly regulated industries have found ways to excel operationally. The aerospace sector, for instance, must comply with stringent government regulations (FAA, DoD, etc.) and demands near-zero defects (much like pharma’s quality requirements). Yet aerospace manufacturers widely implemented Lean and continuous improvement in the 1990s and 2000s. They proved that regulatory compliance and efficiency can go hand-in-hand – by integrating quality controls into lean workflows, aerospace firms meet all mandates (e.g. traceability under air safety regs) and drive out waste.

Similarly, automotive companies face safety and environmental regulations, but have achieved world-class manufacturing efficiency through methodologies like the Toyota Production System. The truth is that pharma’s regulation excuse often masks internal issues: risk-aversion, outdated mindsets, and a lack of operational innovation. As one industry veteran put it, pharma manufacturing “lags far behind the innovative techniques found in other industries” not just because of rules, but due to **high regulatory comfort zones and ineffective incentives to change. In short, compliance requirements are real – but they should be the floor, not a ceiling. World-class operational performance is possible within regulations if pharma companies stop hiding behind them.

 

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3.0 Leadership Failures: Missing Boldness and Know-How

If regulations aren’t the whole story, a hard look in the mirror reveals a major root cause: leadership and culture. For years, many pharma executives de-prioritized manufacturing strategy, focusing on R&D and marketing while the factory “just made the product”. High profits masked inefficiencies, so leaders didn’t invest in new production technologies or process improvement capabilities. In the 1990s, when pharma profit margins hit historic highs, there was “little attention paid to speed and cost” in operations – there was no “burning platform” for change.

This lack of urgency bred complacency at the top. Even as global competition and pricing pressure have intensified, many senior pharma leaders still lack understanding of modern operations and technology. A 2018 industry analysis pointed to a “widespread lack of understanding of lean’s strategic value at the senior leadership level”, resulting in lean programs that are isolated or unsustained. In other words, top executives often don’t get how powerful systematic operational excellence can be, or how to implement it. Without leadership vision and commitment, improvement initiatives falter.

Bold decision-making is further hampered by risk-aversion in the C-suite. Pharma leaders are trained to be cautious – after all, patient safety and compliance are paramount. But excessive caution can cross into conservatism that rejects change. Even when cost-saving or quality-improving innovations exist, leaders often fear the regulatory unknowns or potential short-term disruptions. Roger Nosal, a Pfizer operations VP, noted that both industry and regulators often “suffer from risk aversion”, preferring the status quo unless an innovation guarantees equal or better quality from day one. This mindset leads companies to stick with decades-old equipment and paper-based processes rather than adopt digital systems or advanced analytics that other sectors use routinely. It also means few “bold bets” on transformational change.

For example, Pfizer pioneered real-time quality release testing (using sensors/models to verify product quality instantly) and got it approved for several products – a true operational innovation. Yet the company abandoned this approach because “maintenance costs and regulatory lifecycle burden” (constant post-approval filings for minor adjustments) negated the business case. Here, leadership could have worked with regulators to refine the approach or pressed for regulatory flexibility given the clear benefits. Instead, risk-aversion won out, and a promising innovation died on the vine.

In contrast, other regulated industries have shown leadership boldness in transforming operations. Automotive CEOs in the 1980s–90s, facing Japanese competition, personally championed lean manufacturing and retrained their organizations. The lesson is clear: without informed, committed leadership, operational excellence cannot thrive. Pharma’s leaders must educate themselves on modern manufacturing and quality science, recruit operations talent into top ranks, and set ambitious improvement targets. As a McKinsey report urged, today’s CEOs/COOs “may need to make bold changes to their operations strategy” for the company to remain resilient. That means moving beyond lip service to truly integrate productivity, quality, and innovation goals into the corporate vision. When leadership treats manufacturing as strategic – not as a back-office afterthought – organizations are empowered to take calculated risks and break the inertia.

 

4.0 QA as a Roadblock: Quality Culture or Compliance Culture?

No discussion of pharma’s operational challenges is complete without examining the role of Quality Assurance (QA). QA is the guardian of product quality and patient safety – a critical function in any drug company. But in many organizations, QA has also become a notorious bottleneck. The intent of QA oversight is to prevent errors, yet ironically it often slows progress and innovation. One telling metric: even with “right-first-time” initiatives, the biggest delay in releasing a finished batch is often the QA review and approval process. Missing information, laborious paper reviews, and back-and-forth clarifications between QA and production can add days or weeks to every batch. When 30% of staff hours are tied up in documentation and compliance tasks, it’s easy to see how QA – if not modernized – can severely drag down efficiency.

The problem is not QA’s existence (which is non-negotiable) but rather its approach and capability. In some pharma companies, QA teams have an audit-policing mindset – enforcing rules rigidly, focusing on paperwork perfection – rather than a quality partnership mindset that would emphasize building quality into processes and working collaboratively to improve them. This compliance-centric culture often stems from skill gaps: QA staff are well-versed in regulations and SOPs, but may have lower “operational IQ” or exposure to continuous improvement methods. Likewise, their “regulatory IQ” may be limited to a by-the-book interpretation of rules, without a nuanced understanding of risk-based compliance or the flexibility regulators allow.

The result is QA groups that default to “No, we can’t do that” when faced with change, acting as gatekeepers rather than problem-solvers. For instance, a company might propose digitizing batch records or adopting a new technology, but QA raises dozens of compliance questions or insists on lengthy validation proof, demoralizing the initiative. Certainly, diligence is needed – but excessive conservatism can hinder progress and even quality itself. An FDA quality director bluntly noted that deeply entrenched validation approaches and fear of regulatory issues are major barriers to innovation in pharma. In many cases, the perceived regulatory strictures are tougher than the actual rules, due to a lack of up-to-date knowledge.

To turn QA from a roadblock into an enabler, pharma companies need to invest in quality culture and capability. This means training QA personnel in process improvement, data analytics, and risk assessment – so they can confidently allow smarter, efficiency-boosting changes that still meet compliance. It also means instilling a culture where QA’s motto is “How can we do this compliantly?” rather than “Compliance says no.” Some positive signs are emerging: FDA and industry groups have been promoting Quality by Design (QbD) and Quality Culture initiatives, encouraging manufacturers to build quality into processes and use science-based, real-time controls (which actually makes QA’s job easier in the long run).

Leading companies include QA in cross-functional continuous improvement teams, rather than keeping quality siloed. By improving what one might call the “regulatory and operational IQ” of QA staff, pharma can avoid scenarios where lack of understanding freezes progress. When QA professionals truly grasp both the letter and intent of regulations, they can figure out creative solutions to maintain compliance while streamlining a process. In sum, QA should be the guiding hand ensuring robust processes, not a brick wall – and that requires upgrading QA competencies and mindsets across the industry.

 

5.0 Comparing to Other Industries: What Pharma Can Learn

It’s instructive to compare pharma’s operational track record with that of other industries that face equal or greater regulatory burdens, yet have achieved high levels of efficiency, innovation, and employee engagement. Three examples highlight how excuses can be overcome:

  • Aerospace & Defense (A&D): Airplane and defense manufacturers operate under intense safety regulations (FAA rules, military specs like ITAR export controls, ISO/AS9100 quality standards) and must document every part and process. Failure can literally be catastrophic. Despite this, the A&D industry embraced lean manufacturing and Six Sigma in the 1990s–2000s to remain competitive. Companies like Boeing, Lockheed Martin, and their suppliers streamlined production flows, reduced inventories, and improved first-time quality by using Toyota-inspired methods – all while complying with oversight. They achieved this by integrating compliance into efficient processes: e.g. using digital systems for part traceability and quality audits, so that real-time data ensures both regulatory needs and waste elimination. One industry review notes that by combining lean principles with a strong compliance foundation, aerospace firms improved cost, speed, and quality simultaneously. The aerospace case refutes the idea that heavy documentation and rigorous QA must equal sluggish operations – with leadership commitment, they built a culture where “quality is everyone’s job” and continuous improvement coexists with strict standards.

  • Automotive: Automakers have long been subject to safety regulations (crash standards, recalls) and environmental rules (emissions standards). In the 1980s, they faced a crisis of quality and efficiency when Japanese lean production massively outperformed Detroit’s mass production. By the 1990s, virtually all major automakers had adopted lean/TPS principles – focusing on waste reduction, employee empowerment, and built-in quality. The auto industry’s inventory turns (a measure of how many times inventory is cycled per year) far exceed pharma’s. Lean experts often cite inventory as “evil” because excess hides problems. Pharma historically carried 6–8 months of inventory (inventory turns ~2), whereas an efficient automotive supply chain might turn inventory 10–20+ times per year.

    In fact, pharma still ranks near the bottom of all industries in inventory turns performance. Automotive’s lesson was that pressure can spark change: competition created a burning platform, and leaders made operational excellence a strategic pillar. They empowered plant managers and engineers to redesign workflows and invest in automation within the framework of compliance. Today, car manufacturing plants are showcases of advanced robotics, real-time quality monitoring, and relentless cycle-time reduction – all achieved in a regulated environment (each car model must meet safety standards, etc.). Pharma, by contrast, has only recently felt comparable pressure (e.g. from generics, pricing scrutiny) and is playing catch-up on these techniques.

  • Food & Beverage / Consumer Goods: These industries have significant regulatory oversight for safety (FDA/USDA for food, FDA for cosmetics, etc.), though not as stringent as pharma’s GMP. Even so, many food manufacturers have implemented operational excellence programs to minimize contamination risk and improve efficiency – for example, Hazard Analysis and Critical Control Points (HACCP) systems combined with lean sanitation procedures. Companies like Nestlé or Unilever have global continuous improvement networks despite diverse regulatory regimes. Consumer electronics is another interesting comparison: while not regulated for safety in the same way, it faces blistering innovation cycles. Electronics manufacturers mastered fast cycle times, high yields, and employee-driven problem solving to survive (think of the speed of smartphone production lines). Pharma might argue “we’re different, we’re regulated,” but even nuclear power plants – perhaps the most regulated operating environments on earth – utilize rigorous operational excellence frameworks (like the Navy’s nuclear program’s culture of systems discipline and continuous training) to achieve extraordinary safety and reliability records. The common thread is that these industries foster a culture where compliance is the baseline, continuous improvement is the mindset. They also invest heavily in employee training, data systems, and cross-functional collaboration so that meeting regulations does not mean accepting inefficiency.

Case studies underscore both the successes and failures in pharma’s own attempts to improve. On the positive side, some pharma companies have made strides: for instance, Amgen significantly improved its inventory turns (by ~6.5% annually since 2009) through focused lean efforts, directly translating to freed-up cash and better service levels. Top-quartile pharma manufacturers (according to benchmarking studies) achieve over three times the productivity of bottom-quartile peers – proof that big improvements are achievable even in this industry. The rapid scale-up of mRNA vaccine manufacturing in 2020–21 is another success story: companies broke traditional timelines by innovating processes on the fly, leveraging real-time data, and closely partnering with regulators to ensure safety – essentially compressing years of operational learning into months. This showed that when urgency is high and leadership is all-in, pharma can indeed “launch a moonshot” operationally.

However, many improvement programs in pharma have sputtered out. A decade ago, Lean Six Sigma was all the rage – big pharma companies launched enterprise-wide initiatives (e.g. “Merck Sigma” at Merck, or programs at J&J) and trained armies of Black Belts. But enthusiasm waned. Today those programs survive only in pockets, mostly limited to manufacturing sub-projects. Why? Analysts cite misunderstandings and lack of sustained leadership support. Some companies treated Lean Six Sigma as a one-time “training” or purely a quality initiative, rather than a holistic business strategy. Others deployed tools in silos (one plant here, one department there) without enterprise alignment, so gains didn’t stick. In a telling observation, after initial lean efforts, “these successes have not been enough to ‘move the dial’ for pharma” overall, and some early adopters regressed once executive attention moved on. The conclusion is that isolated wins won’t last without embedding operational excellence into the DNA of the company. Pharma’s challenge – and opportunity – is to learn from these failures and from other industries’ successes to finally bridge the performance gap.

 

6.0 Data and Benchmarks: Pharma by the Numbers

To quantify the lag, consider a few benchmarks. From 1987 to 2008 (over 20 years), labor productivity in U.S. pharmaceutical manufacturing rose by a mere 0.7% per year, the lowest of any major industry – less than one-third the average productivity growth across all manufacturing. In effect, while other sectors were doubling or tripling output per worker with automation and lean techniques, pharma barely budged. Another metric: asset utilization. Pharma plants often run below optimal capacity – McKinsey estimates average overall equipment effectiveness (OEE) in pharma is only ~35% (meaning facilities are idle or stopped two-thirds of the time), whereas industries like automotive routinely hit 80%+ OEE. Inventory turnover, as mentioned, paints a similar picture: pharma has historically been near the bottom among industries, keeping months of stock on hand, whereas high performers in electronics or consumer goods turned inventory in weeks.

Innovation adoption is also measurable. For example, continuous manufacturing (integrated production vs. stepwise batch processing) has been standard in petrochemicals for decades, but pharma has only a handful of continuous processes implemented even now. It took until the mid-2010s for the first continuous tablet manufacturing line to be approved. Surveys by industry groups (ISPE, etc.) find that pharma ranks behind sectors like automotive, electronics, and even consumer packaged goods in deploying Industry 4.0 technologies (advanced robotics, real-time analytics, IoT devices on equipment). On the employee side, it’s harder to get apples-to-apples data on engagement across industries. Interestingly, pharma employees report relatively high job satisfaction in some surveys – likely due to mission (helping patients) and compensation.

In fact, a broad Glassdoor review found the pharma industry ranked #1 for employee satisfaction with pay. Yet high pay doesn’t automatically equal high engagement in daily work. Anecdotally, many pharma plant workers express frustration at bureaucratic procedures and lack of empowerment to change things (“it’s the SOP, just follow it”). By contrast, companies with strong operational excellence cultures often boast more engaged workforces, because employees at all levels are encouraged to suggest improvements and are equipped to solve problems. The best operations are those where frontline staff feel ownership of both quality and efficiency. Thus, while pharma might not have an engagement crisis per se, there is huge unlocked potential if employees were more involved in continuous improvement – a standard practice in other industries known for excellence.

 

7.0 Overcoming the Challenges: A Path Forward

Pharma can no longer afford to trail its peers in operational performance. The good news is, the very factors that once allowed complacency (big margins, low competition) are fading, creating a new imperative for change. To overcome the excuses and structural issues discussed, pharmaceutical manufacturers should pursue a multi-pronged strategy focused on productivity, innovation, waste elimination, and people engagement:

1. Make Operational Excellence a Strategic Priority (and Keep It There): Leadership must set a clear vision that productivity and quality improvement are top-tier goals, as important as R&D innovation or sales growth. This involves establishing enterprise-wide operational excellence programs with C-level sponsorship. Unlike past initiatives that fizzled, the effort needs continuous reinforcement. Leaders should routinely review operational metrics (cycle time, yield, OEE, inventory turns, etc.) alongside financial and clinical metrics. In practice, this might mean the CEO and COO champion specific bold goals – e.g. “halve our batch release time in 3 years” or “double asset utilization by 2025” – and allocate the necessary resources. Companies could consider creating a Chief Operational Excellence Officer role or similar, ensuring a voice at the highest level for manufacturing and supply chain transformation. When leadership is visibly and consistently involved, it sends the message that “efficient, high-quality operations” are part of the company’s core identity, not a temporary project.

2. Invest in Leadership and Talent Development: Closing the leadership knowledge gap is critical. Pharma executives (and rising managers) should be educated in modern operations management – whether through training programs, cross-industry exchanges, or hiring experienced leaders from other sectors. Bringing in a few lean experts from automotive or tech can jump-start new thinking, but equally important is upskilling current teams. Encourage plant managers, quality heads, and supply chain directors to learn about emerging technologies (AI, advanced automation, digital supply chain tools) and regulatory science advances. Some companies rotate high-potential leaders through operations roles to broaden their exposure. The goal is a leadership team that feels as comfortable talking about manufacturing automation or deviation reduction as they are discussing clinical trial data. When top leaders truly grasp the interplay of compliance, technology, and efficiency, they can make bolder, smarter decisions. They’ll also be less likely to accept “regulation” as an excuse when they know other industries found solutions. In short, create leaders who are champions of both compliance and continuous improvement.

3. Transform Quality Assurance into Quality Enablement: QA organizations should evolve from purely policing compliance to actively enabling excellence. This starts with training QA personnel in lean and Six Sigma concepts, data analysis, and risk-based thinking. Quality staff should be embedded in improvement teams on the shop floor, so they understand processes in depth and can suggest compliant streamlining. One practical recommendation is to implement “Quality by Design” and real-time release principles, where QA focuses on ensuring the process is robust upfront (through science and data), rather than catching defects at the end. Companies can also adopt modern IT systems for quality management – e.g. electronic batch records and automated deviation management – to eliminate the tedious manual work that consumes QA time. This not only speeds up QA checks (reducing the batch release delays) but improves data integrity. Another key step is fostering a culture of partnership between QA and operations. For every new improvement idea, instead of QA being the department of “no,” make them co-designers of the solution – task them with figuring out how to meet regulatory requirements in a new way rather than defaulting to old ways. Regulators themselves encourage innovation in quality (FDA’s recent Quality Management Maturity initiative, for example, aims to reward more proactive quality systems). Internally, pharma companies could measure QA not just on compliance metrics (audit findings, deviations) but also on efficiency metrics like review cycle times and proportion of “right-first-time” documentation – signaling that efficient quality is the aim. With higher operational and regulatory IQ, QA can become a linchpin that assures patient safety while accelerating improvement, rather than a roadblock.

4. Embrace Digital and Automation Technologies: Pharma manufacturers need to aggressively adopt the technology toolkit that other industries have used to leap ahead. This includes automation of manual tasks, sensors and Internet of Things (IoT) devices for real-time monitoring, data analytics (even AI) for process optimization, and digital platforms that connect the whole supply chain. For example, implementing an electronic batch record system can eliminate manual data entry errors and allow real-time review, potentially enabling batch release in hours instead of days. Using AI-based scheduling tools can optimize production plans far better than spreadsheets, reducing downtime and inventory. Robotics or continuous processing equipment can run with less human intervention, cutting batch cycle times and variability. Importantly, these innovations should be pursued with regulatory engagement – e.g. working with the FDA’s Emerging Technology Team for guidance on novel manufacturing tech. Case studies show that when companies present a strong scientific rationale, regulators are open to approving new methods (several continuous process approvals in recent years attest to this). The mindset should be “automation to augment humans” – free operators and technicians from rote tasks so they can focus on process improvement and problem-solving, which computers can’t do. By leveraging advanced technologies, pharma can simultaneously improve compliance (through better data and control) and efficiency. Other industries are already reaping huge gains here; pharma cannot remain a digital laggard.

5. Cultivate a Continuous Improvement Culture at All Levels: Tools and tech alone won’t sustain operational excellence – it requires an empowered workforce continually looking for ways to improve. Pharma companies should borrow a page from the Lean/Toyota playbook: train every employee, from operators to scientists, in basic problem-solving and waste identification. Encourage daily or weekly team huddles where front-line staff can raise issues (a machine bottleneck, an onerous form, a frequent minor deviation) and suggest fixes without fear of blame. Recognize and reward employees who contribute ideas that improve productivity or quality. This is a shift for an industry where historically deviation = blame. But a true continuous improvement culture treats mistakes and problems as opportunities to learn and improve the system, not as individual failings. Some practical steps include implementing Kaizen suggestion programs, conducting gemba walks (where managers regularly go to the production “floor” to see issues firsthand), and making improvement a key performance indicator for departments. By involving employees, companies also improve engagement – people feel heard and see the impact of their contributions, which boosts morale and retention. It’s worth noting that lean principles explicitly focus on respect for people and development of people. Pharmaceutical firms that have tried this on a small scale (for example, Pfizer’s “Integrated Manufacturing Excellence” training for operators or Novartis’s continuous improvement academies) have seen not only efficiency gains but also higher job satisfaction scores. Over time, a culture of continuous improvement becomes self-sustaining – employees at all levels will seek out waste to eliminate, whether it’s excess inventory, redundant testing, or tedious paperwork, and they will know how to address it within the bounds of quality compliance.

6. Partner with Regulators and Benchmark Externally: Finally, overcoming the “we’re regulated” hurdle is much easier if you bring regulators into the journey. Rather than keeping authorities at arm’s length out of fear, leading companies work transparently with them on modernization efforts. This might involve inviting FDA/EMA representatives to visit your advanced facilities, sharing data on how a new process maintains or improves quality, and even helping shape new guidelines (as some companies did during the FDA’s Process Analytical Technology initiative. When regulators see a strong quality culture and technical competence, they are more likely to be flexible on how requirements are met. Additionally, pharma should actively benchmark against other industries – send teams to tour a best-in-class automotive plant or a semiconductor fab. Such visits can be eye-opening for pharma professionals, revealing what “good” looks like in terms of cycle times, automation, and empowered teams, even under strict controls. Cross-industry conferences or hiring can also inject fresh perspectives. The goal is to break the insular view (“pharma is unique”) and show that many operational challenges have been solved elsewhere in regulated contexts. If pharmaceutical ops teams learn how airlines manage safety and quick turnarounds, or how food producers achieve six-sigma quality on packaging lines, they might discover creative approaches applicable to pharma. In essence, don’t reinvent the wheel – adapt and adopt proven practices from wherever you can, and work with regulators to ensure those practices are compliant.

 

8.0 Conclusion: No More Excuses – It’s Time for Pharma to Excel

Pharma’s mission of delivering safe, effective medicines will always require rigorous oversight and caution – that will not change. But being careful doesn’t have to mean being slow or wasteful. The persistent gap in operational excellence between pharma and other industries is not due to an immutable law of nature; it is the result of past choices and mindsets that can and must change. Companies can no longer afford leadership teams that are aloof from operations, cultures that treat compliance and efficiency as trade-offs, or QA departments that say “no” to innovation. The competitive and public health stakes are too high. Fortunately, the path forward is clear. By learning from industries that thrived under regulation, pharma can adopt best practices to streamline processes without compromising quality. By rejecting tired excuses and tackling internal shortcomings head-on – upgrading leadership knowledge, empowering QA, engaging employees, and investing in technology – pharma manufacturers can achieve breakthroughs in productivity and agility comparable to their scientific breakthroughs in the lab.

The next decade should be one in which pharmaceutical operations catch up with, and even lead, the world in operational excellence. Imagine drug plants with digital “no-touch” documentation, releasing batches in real time with near-zero errors. Imagine supply chains driven by AI that minimize shortages and inventory. Imagine passionate employees who feel just as proud of fixing a process bottleneck as they do of the medicine’s therapeutic impact. These are not fantasies – the technologies and methods exist today, proven in other fields. It will take vision and courage to implement them in pharma, but the rewards are immense: lower costs (making drugs more affordable), faster response to patients’ needs, less waste, and more fulfilling jobs for the workforce. Pharma has long been a laggard in operational excellence; it now has every reason to become a leader. The companies that seize this moment – shedding the old excuses, transforming their culture, and relentlessly focusing on efficient, quality-centric operations – will not only outperform their peers, they will better serve patients and ensure their own relevance in a rapidly evolving healthcare landscape. The prescription for pharma’s operational woes is in hand – now it’s time to take the dose and act.

 

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Nagesh Nama

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