How Regulatory Readiness Can Shape Pharma's Global Growth

In pharma, quality is no longer just about passing inspections. It is about building a culture that protects patients, identifies risks before they escalate, and keeps global operations consistently ready. From strengthening quality systems across India, the US, and Europe to navigating evolving FDA, EMA, and MHRA expectations, will depend on how effectively companies embed quality into everyday decisions.

In an interaction with Thiruamuthan, Assistant Editor at India Pharma Outlook, Rashida Najmi, Chief Quality Officer, Piramal Pharma Limited, discusses the evolving quality and regulatory priorities shaping global pharmaceutical operations, with a focus on inspection readiness, patient safety, and sustainable growth.

With extensive experience across global quality and regulatory functions, Rashida has led compliance initiatives across India, the US, and Europe, strengthening quality systems and enabling regulatory approvals across diverse pharmaceutical operations.

Read the full interview below to gain deeper insights into building quality excellence for global pharma growth.

From managing quality across sites in India, US, and Europe to overseeing global regulatory responsibilities, what experiences have most shaped your approach to building a strong quality culture?

Managing quality across India, the US and Europe has reinforced one fundamental belief: regulatory requirements may differ across markets, but the purpose of quality remains universal—to protect the patient. The real challenge for a global pharmaceutical organization is not merely complying with multiple frameworks but establishing a common quality philosophy that is understood and consistently practiced across every site.

My experience has also shown that policies, audits and oversight alone cannot build a strong quality culture. Culture is reflected in the decisions people make when no one is watching. Employees must understand why a process matters, how a deviation could affect patients and their individual responsibility within the quality system. When quality is built on trust, knowledge and accountability, organizations move beyond inspection-led compliance towards continuous readiness.

Regulatory inspections have been another important source of learning. Regulators should be viewed as partners in strengthening the healthcare ecosystem, with their observations helping organizations identify emerging risks and evolving expectations. Any learning from one site should be assessed across the wider network rather than treated as an isolated issue.

Ultimately, quality cannot remain the responsibility of the quality function alone. Manufacturing, supply chain, engineering, procurement, technology and leadership all influence the integrity of the final product. Sustainable quality comes from shared ownership, harmonized systems, transparent escalation and continuous learning across the organization.

Having worked across multiple markets, sites and regulatory environments, what are some quality or compliance signals that pharma leaders often underestimate until they become bigger business risks?

One of the most underestimated signals is the recurrence of minor deviations, documentation errors or repeat observations. Individually, these may appear operational, but recurring patterns can indicate deeper weaknesses in training, process design, investigation quality or management oversight. Leaders must look beyond whether an issue has been closed and assess whether its root cause has genuinely been addressed.

Another critical signal is delayed escalation. When employees hesitate to report concerns, whether due to fear, unclear accountability or pressure to meet timelines it can allow manageable issues to become significant compliance and business risks. A healthy quality culture is one where concerns are surfaced early and addressed transparently.

Data integrity indicators also require close attention. Unusual data trends, excessive manual interventions, incomplete audit trails or inconsistencies across systems may signal vulnerabilities even when there is no confirmed breach. As operations become increasingly digital, companies must ensure that technology, governance and employee behavior evolve together.

Supplier-related risks are also frequently underestimated. In a globally interconnected industry, changes in supplier performance, material variability or geopolitical conditions can affect product quality and continuity of supply. Quality leaders must therefore monitor leading indicators across the entire value chain, not just within their own facilities. Early identification and cross-functional action can prevent a quality concern from becoming a regulatory, supply or reputational crisis.

A principle that guides her decisions: Do what is right for the patient, even when no one is watching. When patient safety guides every decision, quality becomes a matter of personal responsibility—not merely regulatory compliance.

As FDA, EMA, MHRA and other regulators increasingly focus on the strength of quality systems, how should companies move from preparing for inspections to maintaining continuous inspection readiness?

Continuous inspection readiness begins with a shift in mindset from viewing an inspection as an event to treating compliance as part of everyday operations. Companies should not need to create a temporary “inspection-ready” environment when an audit is announced. The systems, records, facilities and teams should consistently reflect the standards expected by regulators.

This requires strong governance and timely visibility of quality risks. Leaders should regularly review trends across deviations, complaints, CAPAs, change controls, data integrity and supplier performance rather than assessing them independently. Internal audits and mock inspections are useful, but their purpose should be to test the effectiveness of the quality system and identify systemic weaknesses, not merely prepare employees to answer inspectors’ questions.

Technology can significantly strengthen readiness by improving data accuracy, traceability and access to real-time insights. However, digital platforms are effective only when supported by robust processes and capable teams. Organizations must invest continuously in training so that employees understand not just what a procedure requires, but why it matters and how their decisions affect product quality and patient safety.

For companies operating across multiple sites, learning must also travel quickly. A regulatory observation, audit finding or emerging risk identified at one location should trigger an assessment across the entire network. Ultimately, continuous inspection readiness is the outcome of a strong quality culture, transparent escalation, effective governance and consistent execution maintained every day, irrespective of whether an inspection is scheduled.

For a pharma company looking to enter new markets, how early should regulatory strategy and quality readiness become part of the growth plan?

Regulatory strategy and quality readiness should be embedded at the very beginning of a company’s growth plan, not introduced after a product is developed or when a market-entry timeline has been finalized. Decisions related to product development, clinical strategy, facility design, technology transfer, supplier selection and data generation can all influence whether a product ultimately meets the expectations of the target market. Addressing regulatory requirements late often results in additional studies, process changes, delayed filings and higher costs.

Companies should therefore identify the applicable regulatory pathways, product-specific risks and evidence requirements while evaluating the market opportunity itself. Quality, regulatory, R&D, manufacturing, supply chain and commercial teams must work together from the outset so that growth ambitions are aligned with the organization’s operational and compliance capabilities.

Readiness must also extend beyond securing an approval. Before entering a market, companies should assess whether their quality systems, supply network and teams can consistently meet post-approval obligations, manage changes, respond to safety signals and maintain a reliable supply. This is especially important when operating across markets where regulatory expectations and implementation timelines may differ.

When quality and regulatory strategy are integrated early, they become enablers of growth rather than checkpoints that slow it down. They improve predictability, reduce avoidable rework and build confidence among regulators, customers and partners, creating a stronger foundation for sustainable global expansion.

With global operations increasingly involving CMOs, multiple sites and complex supply networks, where do you see the biggest gaps in maintaining consistent quality and regulatory control?

The biggest gap often lies in fragmented ownership. As operations expand across CMOs, manufacturing sites and suppliers, responsibilities can become distributed without a single, end-to-end view of quality risk. While activities may be outsourced, accountability for product quality cannot be. Companies need clearly defined governance, escalation pathways and quality agreements that establish expectations beyond contractual compliance.

A second challenge is inconsistency in standards and execution. Different sites and partners may operate with varying levels of regulatory maturity, digital capability and quality culture. Organizations should establish harmonized minimum standards while allowing for market-specific requirements. This must be reinforced through risk-based audits, regular performance reviews and continuous capability-building—not only periodic assessments.

Limited visibility across the network is another significant gap. Quality data often remains within separate systems, making it difficult to identify common trends across deviations, CAPAs, complaints, supplier performance and change controls. Integrated data and common metrics can help companies detect weak signals early and intervene before they affect product quality or supply continuity.

Change management also requires stronger control. A change involving a raw material, process, equipment or site can have consequences across several products and markets. Companies need cross-functional mechanisms to assess the regulatory, quality and supply impact of every significant change. Ultimately, consistent control depends on treating the entire external and internal network as one quality ecosystem, supported by shared standards, transparent data and clear accountability.

Regulatory readiness is often viewed as a safeguard against compliance issues. How can pharma leaders turn it into an enabler of market access, customer confidence, and sustainable global growth?

Regulatory readiness creates value when it is treated as a business capability rather than a defensive compliance measure. Strong quality systems, reliable data and a clear understanding of regulatory expectations enable companies to make faster, better-informed decisions during product development, filing and market entry. This reduces avoidable rework and improves the predictability of approval and launch timelines.

It also strengthens confidence among customers and strategic partners. In the pharmaceutical industry, particularly when selecting a CDMO, customers evaluate not only technical capabilities and capacity, but also inspection history, data integrity, quality governance and the ability to respond to evolving regulations. A consistently inspection-ready organisation is therefore better positioned to become a long-term partner and support products across their lifecycle.

Readiness can also accelerate access to new markets. When regulatory requirements are considered early, companies can generate the right evidence, design appropriate processes and build scalable systems from the outset. This makes it easier to adapt submissions and operations across jurisdictions without compromising standards or recreating significant parts of the development program.

Ultimately, regulatory readiness supports sustainable growth by protecting supply continuity, reducing disruption and strengthening trust with regulators, customers and patients. It does not guarantee that challenges will never arise, but it enables organizations to identify risks earlier, respond more effectively and expand with greater confidence. In that sense, quality and regulatory readiness are not costs of doing business; they are strategic assets that determine how reliably a company can grow.

5 Key Leadership Lessons from Rashida:

• Always begin with the patient: I encourage leaders to ask what is right for the patient before making any quality, regulatory or business decision.
• Build quality into the growth strategy: I believe quality and regulatory readiness must shape product development, investments and market-entry plans from the very beginning.
• Create an environment where people speak up: I have learned that leaders must make employees feel confident about raising concerns and escalating risks without fear.
• Use data to anticipate risks: I would advise leaders to look beyond individual incidents and use connected data to identify patterns before they become larger problems.
• View regulators as partners: I see regulatory engagement as an opportunity to learn, strengthen systems, and build the trust required for sustainable global growth.

As quality organizations gain access to more operational and compliance data, how can leaders use these insights to spot risks earlier and move from reacting to problems to preventing them?

The real value of quality data lies not in how much an organization collects, but in its ability to connect information and act on it early. Leaders should move beyond reviewing individual deviations, complaints, CAPAs or audit findings and examine patterns across sites, products, equipment, suppliers and processes. A rise in repeat deviations, delayed investigations, frequent interventions or recurring equipment alarms may appear minor in isolation but, when viewed together, can signal an emerging systemic risk.

This requires a shift from lagging indicators, which explain what has already happened, to leading indicators that show where controls may be weakening. Quality dashboards should therefore track factors such as overdue CAPAs, repeated root causes, training effectiveness, process variability, audit-trail exceptions and supplier performance. Clear risk thresholds and escalation triggers can help teams intervene before a trend develops into a product-quality or compliance event.

Advanced analytics and AI can strengthen this capability by identifying correlations and anomalies that may not be visible through conventional reviews. However, technology should support, not replace, scientific judgment. Data must be reliable, contextualized and reviewed by people who understand the process, while high-impact decisions should continue to involve appropriate human oversight.

Most importantly, insights must lead to timely action. Organisations need governance mechanisms that translate early signals into ownership, investigation and preventive measures across the relevant network. When data is trusted, connected and discussed openly, quality teams can move from documenting past failures to anticipating where the next risk may emerge.

Looking ahead, what will decide pharma companies that are simply compliant from those that use regulatory readiness as a strategic advantage for global growth?

The key differentiator will be whether companies treat compliance as a minimum requirement or use regulatory readiness to improve the way they operate and grow. Simply, compliant organizations tend to respond after a regulation changes, an inspection is announced, or an issue emerges. Strategically ready organizations continuously scan the regulatory environment, anticipate emerging expectations and translate them into early action across their global network.

Quality culture will remain central to this distinction. Policies and technologies can strengthen controls, but sustainable readiness depends on people exercising sound judgment, escalating concerns early and understanding the impact of their decisions on patients. Companies that invest in continuous learning and empower teams to identify risks will be better prepared for increasingly complex products and regulatory expectations.

The ability to connect quality data across sites, suppliers and partners will also become critical. Integrated systems, advanced analytics and AI can help identify weak signals and support faster decisions, provided they are built on reliable data and appropriate human oversight. Equally important will be the ability to apply learning from one site or inspection across the wider organization.

Ultimately, strategic readiness will be reflected in trust and predictability, the confidence of regulators, customers and partners that an organization can maintain quality, manage change and supply products reliably as it expands. The companies that embed regulatory thinking into investment, innovation and market-entry decisions will be able to grow faster and more sustainably without allowing scale to weaken quality.