How life sciences companies are rethinking risk in 2026

A short synthesis on quality culture, supply chain resilience, and sustainability expectations, and how these pressures are reshaping operational priorities globally.

In 2026, “risk” in life sciences looks a lot less like a spreadsheet exercise and a lot more like a full-body workout. The biggest threats to performance are no longer isolated to a single function (quality, procurement, EHS, regulatory). They’re connected, compounding, and very visible: a single quality lapse can trigger a supply disruption, which can trigger reputational damage, which can trigger customer and regulator scrutiny, which can trigger… you get it.

Across pharma, biotech, and CDMOs, three forces are pushing leaders to modernize how they assess and manage risk:

1. Quality culture is becoming a leading indicator, not a “nice-to-have.”
2. Supply chain resilience is now a strategic requirement, not just a sourcing problem.
3. Sustainability expectations are increasingly shaping operations and reporting, especially in Europe.

Below is what’s changing, why it matters, and how it’s reshaping operating models and hiring priorities.

1) Quality culture: from compliance to consistency under pressure

For years, many organizations treated quality risk management as a formal process that “lives” inside the quality unit. But regulators and industry frameworks are pushing in a different direction: risk management needs to be more consistent, less subjective, and better linked to real-world outcomes like reliable supply.

A clear signal is the revision of ICH Q9 (R1) (Quality Risk Management). The revision explicitly calls out persistent challenges in industry practice, including high subjectivity in risk assessments and inadequate management of supply and product availability risks. 

What “rethinking risk” looks like inside quality

In practical terms, more companies are tightening up how risk decisions get made and defended:

• Reducing subjectivity in risk scoring and justification
  This means clearer risk criteria, better calibration across sites, and more structured decision records (so risk acceptance doesn’t vary by who’s in the room). The emphasis on addressing subjectivity is a major theme in ICH Q9 (R1). 
• Treating quality culture as operational infrastructure
  Culture used to be discussed like a soft topic. Now it’s being operationalized: escalation pathways, speak-up mechanisms, error-proofing behaviors, and leadership routines.
• Connecting quality decisions to continuity of supply
  “Right-first-time” and “inspection readiness” are still essential, but more leaders are asking: Does our QMS prevent avoidable disruptions? ICH Q9 (R1) explicitly pushes organizations to think about how risk management relates to supply and availability. 

Why this matters in 2026

Because regulators are increasingly signaling that mature quality systems and culture are tied to reliability. For example, FDA CDER is establishing a Quality Management Maturity (QMM) Program intended to encourage practices that go beyond CGMP. 
That direction of travel is hard to ignore: companies that treat quality as a “minimum requirement” risk falling behind those treating it as a performance system.

2) Supply chain resilience: moving from efficiency-first to risk-balanced

The past few years exposed a reality that life sciences leaders can’t unsee: global supply chains can be fragile, and shocks don’t politely stay in their lanes. In Europe, medicines shortages and dependency concerns have kept resilience high on the policy agenda.

A policy signal: “critical medicines” and security of supply

The European Commission has advanced a Critical Medicines Act approach focused on strengthening supply resilience— including measures like strategic projects, procurement incentives, and efforts aimed at supply chain resilience for critical medicines and ingredients. 

At the same time, public reporting continues to highlight the seriousness of shortages. A European Court of Auditors warning (reported by Reuters) pointed to chronic shortages and highlighted supply chain fragility and reliance on manufacturers outside the EU as a key factor. 

What companies are doing differently in 2026

This is where “risk” becomes a board-level operational topic:

• Dual-sourcing and network redesign (not just supplier qualification)
  Organizations are re-evaluating where single points of failure exist: API sources, packaging components, cold chain lanes, specialty excipients, and even critical utilities at key sites.
• Business continuity planning gets more specific
  Not just “we have a plan,” but: time-to-recover assumptions, validated alternates, clear decision rights, and rehearsed playbooks that connect quality, technical ops, and supply planning.
• Quality + supply planning are getting integrated
  The practical shift: quality metrics are being used to predict supply risk earlier, rather than reacting after a deviation becomes a shortage.

The overall theme is a move away from “lowest cost wins” toward “risk-balanced supply,” where reliability is a strategic differentiator.

3) Sustainability expectations: operational risk now includes disclosure and trust

Sustainability is no longer only an EHS topic or a corporate report. In many regions, it’s becoming a compliance and investor expectation issue—and it can drive operational decisions about suppliers, materials, energy, logistics, and even site footprint.

A key driver in Europe is the Corporate Sustainability Reporting Directive (CSRD) and related EU reporting rules, which require large and listed companies to report on sustainability risks they face and impacts they create. 

What this changes operationally

Even for companies outside Europe, the ripple effects are real when customers, partners, or subsidiaries fall into scope:

• Supplier expectations tighten (data availability, traceability, audit readiness)
• Operational decisions start factoring in reportability (what you can’t measure becomes a risk)
• “Green claims” and reputational risk become more regulated-feeling (because stakeholders expect evidence)

In other words: sustainability is increasingly treated as risk management through transparency.

The common thread: risk is becoming cross-functional and talent-intensive

When quality culture, supply resilience, and sustainability all rise in priority at the same time, a predictable thing happens: companies need leaders who can operate across silos without starting a turf war.

In 2026, many life sciences organizations are strengthening capabilities in areas such as:

• Quality leadership that can drive culture and consistency at scale (not just manage audits)
• Supply chain and procurement leaders who understand regulated manufacturing realities
• Operational excellence and business continuity specialists who can translate risk into action
• Data and governance roles that make risk measurable, comparable, and auditable across sites
• Sustainability / ESG reporting and compliance talent (especially for EU-linked reporting needs) 

This is one reason hiring conversations are shifting from “years of experience” to “scope of systems you’ve influenced.”

What to watch next

If you’re setting operational priorities for 2026, here are three practical questions that reflect where the industry is heading:

1. Can we explain our risk decisions clearly and consistently across sites? (Subjectivity is now a known weakness area in QRM expectations.) 
2. Do we know our single points of failure—and do we have credible alternates? (Policy and shortages pressure are not easing.) 
3. Can we produce sustainability-related data with the same discipline we apply to GMP data? (Reporting expectations are rising, especially in the EU.) 

Risk in 2026 isn’t about being cautious. It’s about being prepared—without slowing the business down.