Building World-Class Global Quality Teams That Break Down Silos

By Marcelo Trevino, independent expert

In part 1 of this series, I explored how cultural intelligence forms the foundation for global quality and regulatory leadership. I examined why regulatory frameworks and quality systems are cultural artifacts, how different regions approach quality philosophically, and why technical mastery alone proves insufficient for leading globally.

Now I turn to operationalizing that cultural intelligence. Understanding cultural differences matters, but translating understanding into organizational structures, communication protocols, and quality cultures that deliver excellence is where theory meets practice.

Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical, they're organizational and cultural. How do you build teams that collaborate effectively across 12 time zones? How do you break down silos between R&D, quality, commercial, clinical, and supply chain? How do you establish quality cultures that transcend geography while respecting regional differences?

This article answers these questions with frameworks tested through real experience managing distributed quality teams, transforming dysfunctional organizational cultures, and building quality systems that leverage global diversity as competitive advantage.

Building High-Performance Distributed Quality Teams

Global collaboration is now the default, not the exception. Quality teams must learn to lead, communicate, and deliver across borders, often without ever sharing a physical space. Research on global team effectiveness identifies critical success factors: structural adaptation, communication protocols, and leadership distribution.

From Geographic Silos to Global Process Pods

Traditional hierarchical reporting structures designed for co-located teams create bottlenecks in global environments. When leading quality transformation at a major industrial technology company, we restructured from geographic silos (U.S. quality, EU quality, APAC quality) to process-based pods: design controls, supplier quality, post-market surveillance. Each pod was globally distributed with representation across time zones.

Results were dramatic. Decision velocity increased significantly as quality decisions no longer waited for sequential approvals across regions. Knowledge sharing improved exponentially. An FDA 483 observation in one region now immediately benefits other operations because the same team owns the process globally, not regionally.

The restructuring met initial resistance. We addressed concerns through "regional anchors," designating regional subject matter experts in each process pod who ensured local regulatory nuances were considered in global decisions. Within six months, initially resistant regional leaders became the strongest advocates, recognizing that being part of global process pods elevated their influence beyond geography.

Communication Protocols: Beyond the Always-On Myth

The "always on" global team is a myth that burns out talent and destroys quality culture. Instead, establish what I call "communication reciprocity," a framework for balanced asynchronicity that respects personal boundaries while maintaining quality responsiveness.

We implemented three simple rules:

1. No expectation of immediate response across time zones unless flagged as urgent (impacting patient safety or imminent regulatory deadline).
2. Record critical quality decisions, don't just discuss them. If decisions weren't documented, they weren't decided.
3. Rotate meeting times quarterly so no region perpetually accommodates others.

These principles transformed retention. Annual turnover in global quality roles decreased dramatically within six months.

During EU MDR technical file preparation, our European quality team needed input from U.S.-based design engineers. Instead of triggering urgent email chains and after-hours calls, the European team documented specific questions in our shared quality system before end of day. The U.S. team responded during their morning, and the European team had answers waiting when they returned. No one worked outside business hours, yet quality projects stayed on schedule.

The key was clarity about urgency. We defined four levels: patient safety (response within 2 hours regardless of time zone), regulatory deadline within 48 hours (response same business day), standard technical quality question (response within 24 business hours), and strategic quality discussion (scheduled during overlapping hours).

Leadership Distribution: Elevating Quality Expertise Everywhere

Global teams thrive when leadership functions are distributed, not centralized. During EU MDR and EU IVDR transitions, I designated regional "MDR or IVDR champions" — technical quality experts, not managers — empowered to make quality decisions within defined parameters.

This recognized that quality professionals in European facilities understood notified body expectations better than I ever would from my location. When questions arose about clinical evaluation requirements, our regional champion had authority to interpret and implement without waiting for my approval.

One moment crystallized this approach. During a notified body audit preparation, an MDR champion recommended a documentation approach contradicting my initial direction. Rather than insisting on my preference, I asked her to explain reasoning. She outlined how our chosen notified body specifically interpreted certain MDR annexes based on recent industry guidance I hadn't yet seen. We implemented her approach, and the audit proceeded without major findings.

Leaders who acknowledge quality expertise wherever it resides and create structures that elevate it build stronger teams.

Breaking Functional Silos: The Hidden Barrier To Quality Excellence

Geographic restructuring solved only half the problem. The more insidious challenge was functional silos: R&D designing products in isolation from quality requirements, commercial making market commitments without consulting quality on feasibility, supply chain selecting vendors without understanding post-market surveillance implications, and clinical teams generating data that didn't address regulatory questions.

These silos create devastating consequences. I've seen product launches delayed significantly because commercial promised features R&D couldn't validate to quality standards. I've watched companies invest heavily in clinical trials failing to address questions regulators actually cared about. The root cause is cultural, not organizational. Each function optimizes for their own metrics, and without cross-functional integration, these strategies inevitably conflict.

The Cultural Transformation: Creating One Quality-Minded Team

At a medical device manufacturer, functional silos had become so entrenched that departments literally stopped speaking to each other. R&D blamed quality for "blocking innovation." Commercial blamed R&D for "missing market windows." Quality blamed everyone for "creating compliance nightmares."

I inherited this dysfunctional culture and knew org charts alone wouldn't fix it. We needed fundamental cultural transformation with quality at the center.

Step 1: Establish Shared Accountability for Quality

We created cross-functional product teams where R&D, quality, regulatory, clinical, supply chain, and commercial all shared accountability for product success and quality excellence. Not "consulted" or "informed," but genuinely accountable.

This shift required changing performance metrics. R&D engineers were now evaluated partly on regulatory approval success and quality performance, not just design completion. Commercial leaders were measured on sustainable revenue through products staying on the market without quality issues. Quality metrics included innovation velocity and time to market, not just compliance rates.

Initial reaction was resistance: "You're asking me to be responsible for things I don't control." My response: "Exactly. Because quality is everyone's responsibility, and product success requires all functions working in concert."

Step 2: Embed Quality Thinking Across All Functions

We instituted "quality and regulatory immersion" for non-quality functions. Every R&D engineer spent time shadowing quality engineers during process validation. Every commercial leader participated in regulatory audits and spent time in manufacturing observing quality control operations. Every supply chain manager attended design reviews to understand how supplier decisions impact product quality.

The transformations were remarkable. R&D engineers who witnessed regulatory reviewers questioning design rationales began incorporating quality thinking into early design phases. They started asking "how will we validate this?" during concept development, not after design freeze.

Commercial leaders who sat through audits stopped making unrealistic market commitments. They understood viscerally that quality issues could destroy market reputation faster than aggressive launch timelines could build it.

We also reversed the flow. Quality professionals spent time with commercial understanding customer needs, with R&D learning about innovation pressures, and with clinical understanding study design challenges. This bidirectional learning built empathy and mutual respect.

Step 3: Create Integrated Planning Rituals Centered on Quality

We established quarterly product portfolio reviews where all functions gathered to evaluate every product from concept through post-market. These weren't status updates; they were strategic decision forums where we made real-time trade-offs with quality and regulatory considerations front and center.

Should we accelerate Product A to capture a market window, knowing it might stress our quality systems? That decision required input from all functions. Everyone had voice and vote. Quality didn't have veto power, but quality considerations carried equal weight with commercial and technical factors.

A Transformative Example: When Quality Considerations Drove the Decision

One memorable moment crystallized the cultural transformation. A cross-functional team was preparing to launch a new device. Commercial identified a significant market opportunity with a narrow window. R&D had a technical solution ready. Quality completed validation. Regulatory approval was secured. By all traditional measures, we were ready to launch.

But during integrated planning review, clinical raised a concern. Our clinical evidence package, while regulatorily sufficient, wouldn't convince surgeons to adopt the device. Supply chain separately noted that accelerated timelines had stressed supplier quality systems, with early indicators of potential quality issues in incoming materials.

The team collectively decided to delay launch based primarily on the quality considerations. Commercial would miss their market window. Competitors would enter first. But the integrated decision prioritized long-term quality over short-term revenue capture.

We spent additional time conducting supplementary clinical work and strengthening supplier quality processes. When we launched several months later, competitors had entered first. But our clinical evidence and quality reputation captured significant market share quickly. The integrated decision, with quality considerations driving the outcome, produced better long-term results than rushing to market would have.

Celebrating this decision sent a powerful cultural message: cross-functional collaboration and quality excellence mattered more than individual functional metrics.

Step 4: Celebrate Cross-Functional Quality Excellence

We changed recognition systems to reinforce quality collaboration. Instead of Quality Team of the Year, we created Cross-Functional Excellence Awards recognizing teams demonstrating exceptional collaboration with quality at the center.

The Measurable Impact Of Quality Culture Transformation

The cultural transformation produced tangible results:

• Product approval timelines decreased significantly because quality and regulatory input happened early.
• Post-market quality issues declined dramatically through R&D, supply chain, and quality collaboration from the start.
• Customer complaints about quality decreased substantially as products were designed with quality integrated from conception.
• Field actions dropped significantly across all product lines.
• Cost of quality decreased substantially as prevention replaced detection and correction.
• Customer satisfaction and market reputation improved markedly as quality became a competitive differentiator.

Employee engagement scores in cross-functional collaboration increased substantially. Quality professionals reported higher job satisfaction because they felt like strategic partners rather than compliance police.

Sustaining Quality Culture: The Ongoing Challenge

Breaking silos and building quality culture is never permanent. Organizational change creates pressure to revert to familiar patterns. Maintaining a cross-functional quality culture requires constant vigilance and reinforcement.

I instituted "culture check" sessions where teams anonymously reported when they felt silos reemerging or quality being deprioritized. We also designated cross-functional collaboration and a quality mindset as explicit leadership competencies in promotion decisions. You couldn't advance to senior leadership without demonstrating an ability to work across functions effectively with quality as a core value.

Leadership Behaviors That Build Quality Excellence Globally

Academic research on cross-cultural leadership identifies behaviors predicting success across diverse teams. My experience validates these while adding practitioner perspectives specifically for quality and regulatory leaders.

1. Demonstrate Authentic Curiosity About Quality Cultures

Cultural competence is a lifelong commitment to learning, not a training module you complete. When establishing operations in Latin America, I spent time not in conference rooms but in manufacturing facilities, asking operators to teach me their workflows and quality checks.

That investment paid dividends. When implementing Lean Six Sigma improvements later, adoption rates were exceptional because changes reflected operators' quality insights and cultural approaches. Spending time where work actually happened revealed quality insights no conference room presentation could provide.

2. Make Cultural Adaptation Visible in Quality Leadership

Leaders set the cultural tone. When I schedule global team meetings, I rotate times and publicly acknowledge whose evening or early morning we're consuming. Saying "I know it's early morning in Asia, thank you for joining" acknowledges sacrifice and demonstrates respect.

I also adapted my communication style regionally around quality expectations. With U.S. teams, I'm direct and concise. With colleagues in some Asian markets, I learned to provide more context and allow longer processing time. With European teams, I emphasized technical precision and documentation. These adaptations represented respect for how different cultures process quality information.

3. Institutionalize Regional Voice in Quality Strategy

During management reviews, I require that each regional quality lead present directly to executive leadership, not through me. This elevates regional quality expertise and prevents my cultural biases from filtering global quality reality.

At one management review, our regional quality lead in Asia presented data showing complaint rates in their region were substantially lower than other regions, but investigation times were longer. She explained that customers in that region provided far more detailed initial complaints, allowing for more thorough root cause analysis. The extra time invested prevented recurrence more effectively than faster but superficial investigations.

4. Invest in Language and Quality Terminology

I've led quality teams where I was the only native English speaker in the room. Learning basic quality terminology in other languages demonstrated respect and improved communication. More importantly, I learned to speak English more clearly: avoiding idioms, slowing my pace, confirming understanding.

The phrase "let's circle back on this quality issue" means nothing to non-native English speakers. "Let's discuss this quality concern again tomorrow at 10 a.m." is clear. We developed glossaries of quality terms with culturally appropriate explanations, not just direct translations, ensuring everyone understood quality concepts consistently.

Practical Framework For Aspiring Global Quality Leaders

For quality and regulatory professionals stepping into global roles, consider this framework:

Year One: Listen More Than You Lead

Your technical expertise earned you the role; your cultural humility will determine your success. Spend your first year understanding how different regions interpret quality and regulatory requirements. Schedule listening tours where you visit each region and spend time observing quality work, not just conducting meetings.

Ask questions like: What quality challenges keep you up at night? What misunderstandings from headquarters cause the most friction around quality? What local quality practices work well that headquarters doesn't understand?

Years Two to Three: Build Quality Systems, Not Monuments

Resist the urge to impose your previous company's quality system. Design flexible quality frameworks that accommodate regional needs within global standards. Your CAPA system should adapt to cultural differences in root cause analysis while maintaining consistent quality decision criteria.

This is when you establish infrastructure for global quality collaboration: communication protocols, quality translation layers, distributed decision-making frameworks. Build quality systems that outlast your tenure.

Years Four to Five: Develop Regional Quality Leadership

Your job now is building quality teams where expertise thrives regardless of location. Identify high-potential regional quality leaders and actively sponsor their development. Send them to different regions for extended rotations. These rotations create quality leaders who understand multiple regulatory and quality cultures viscerally, not theoretically.

Ongoing: Never Stop Learning

Regulatory environments evolve constantly. Commit to reading at least one IMDRF guidance document monthly, attending two international quality conferences annually, and scheduling quarterly calls with quality consultants in each major market.

The Integration Challenge And Future Of Quality Leadership

The most difficult aspect of global quality leadership is integration: synthesizing regional quality insights and regulatory requirements into coherent global strategy while respecting local autonomy.

At another medical technology organization, we faced critical decisions about our AI diagnostic platform's regulatory pathway. The U.S. route suggested pursuing FDA Breakthrough designation. The European pathway under IVDR demanded extensive clinical validation. Other regions required bridge studies. These are three viable but incompatible strategies.

We developed a phased approach: pursue FDA Breakthrough designation first, leveraging a collaborative FDA process to refine requirements. Use that FDA interaction to strengthen an EU clinical evaluation strategy. Conduct bridge studies in parallel, designed to satisfy regional requirements while demonstrating quality system adaptability.

This integrated strategy recognized that regulatory pathways and quality approaches, while different, could be synergistic. FDA feedback improved our EU submission. Regional bridge study data enhanced our post-market surveillance globally. Regional approaches became mutually reinforcing.

Conclusion: The Path Forward

The medical device industry's future is irreversibly global. Technologies like AI/ML, digital health, and connected devices don't recognize borders. Neither can quality and regulatory leadership.

Quality excellence in this future requires leaders who understand that quality is culturally constructed, that regulatory frameworks reflect cultural values, and that excellence requires respecting diversity while maintaining uncompromising standards for patient safety.

This two-part series explored both cultural intelligence foundations and organizational excellence frameworks necessary for global quality leadership. We examined why regulatory frameworks are cultural artifacts, how to build distributed teams that leverage diversity, how to break down functional silos, and what leadership behaviors build quality cultures transcending geography.

The journey from cultural awareness to organizational transformation is long and challenging. It requires technical mastery, cultural intelligence, organizational wisdom, and unwavering commitment to quality excellence. But for leaders dedicated to protecting patients globally, it's the only path forward.

Twenty-five years into this journey, I'm more convinced than ever: the future of quality and regulatory leadership requires leading people across time zones, across cultures, across regulatory frameworks, and across functional boundaries toward shared commitment to quality excellence and patient safety.

Quality isn't just what we do; it's who we are. Regulatory compliance isn't just what we achieve; it's how we protect patients. Excellence isn't just what we pursue; it's what we deliver through integrated global effort that respects diversity while maintaining uncompromising standards.

The work is hard. The responsibility is immense. The rewards are extraordinary. And the need has never been greater for leaders who understand that global quality and regulatory excellence require both technical mastery and cultural wisdom, both systematic thinking and human understanding, and both uncompromising standards and respectful adaptation.

This is the future of quality and regulatory leadership. This is the challenge we must embrace. This is the excellence we must achieve. For patients. For teams. For the future of healthcare globally.

About The Author:

Marcelo Trevino has more than 25 years of experience in global regulatory affairs, quality, and compliance, serving in senior leadership roles while managing a variety of medical devices: surgical heart valves, patient monitoring devices, insulin pump therapies, surgical instruments, orthopedics, medical imaging/surgical navigation, in vitro diagnostic devices, and medical device sterilization and disinfection products. He has an extensive knowledge of medical device management systems and medical device regulations worldwide (ISO 13485:2016, ISO 14971:2019, EU MDR/IVDR, MDSAP). He holds a BS in industrial and systems engineering and an MBA in supply chain management from the W.P. Carey School of Business at Arizona State University. Trevino is also a certified Medical Device Master Auditor and Master Auditor in Quality Management Systems by Exemplar Global. He has experience working on Lean Six Sigma Projects and many quality/regulatory affairs initiatives in the U.S. and around the world, including third-party auditing through Notified Bodies, supplier audits, risk management, process validation, and remediation. He can be reached at marcelotrevino@outlook.com or on LinkedIn.