The difference between a good plan and a great outcome is execution. Management and operations is where strategy becomes schedules, budgets, decisions, and day-to-day performance. Whether you’re scaling a biotech, stabilizing a troubled asset, integrating a new acquisition, or preparing for a critical audit, operational leadership is what keeps teams aligned and work moving without sacrificing compliance or quality.
Terraforme Biosciences supports organizations that need practical operating experience, not just advice. We help leaders translate priorities into clear workstreams, establish accountability, remove bottlenecks, and build systems that make performance repeatable. The goal is simple: smoother operations, faster delivery, and fewer surprises while staying inspection-ready.
problems we solve
New Process Implementation
Implementing a new process in regulated life sciences is rarely just “training people on a new SOP.” It’s a coordinated change across roles, systems, documentation, materials, and quality controls, often under real time pressure. If those pieces don’t move together, teams default to old habits, records become inconsistent, and the process never truly stabilizes.
We help you implement new processes in a way that actually sticks. That means defining the intended workflow, building the supporting documentation and tools, clarifying responsibilities, and aligning the quality controls that prove the process is working. We also support rollout planning, training effectiveness, early-stage monitoring, and rapid iteration so the process becomes reliable quickly without creating unnecessary friction.
Scale Up
Scale-up exposes operational gaps that were easy to tolerate at smaller volumes: informal handoffs, tribal knowledge, inconsistent training, and “hero-based” execution. As teams grow, those gaps become bottlenecks slowing release, increasing deviations, and creating uneven performance across shifts, departments, or product lines.
We help organizations scale without losing control. That means strengthening operational cadence, defining interfaces between functions, improving planning and prioritization, and building right-sized governance and metrics. The outcome is more predictable delivery, clearer accountability, and operational capacity that grows with your business without creating unnecessary bureaucracy.
Multi-Site Integrations
When larger life sciences organization acquires a new site, the technical integration is only half the challenge. The harder work is operational and cultural: aligning expectations, decision rights, quality systems, reporting, and performance standards across regions. Without a structured integration plan, organizations end up with parallel processes, inconsistent documentation, and friction between global standards and local realities risking compliance and slowing execution.
We support multi-site integrations by translating corporate requirements into practical site-level execution. We help map differences between systems, define what must be standardized versus what can remain local, and build a realistic integration roadmap with sequencing, owners, and measurable milestones. We also support change management, governance routines, and cross-site communication so the acquired operation becomes fully integrated, inspection-ready, aligned, and able to perform at the level the broader organization expects.
our approach
Operational clarity: Define roles, responsibilities, and decision rights so work moves without confusion.
Repeatable cadence: Build routines for planning, prioritization, escalation, and reporting that teams can sustain.
Cross-functional alignment: Improve handoffs between Quality, Operations, Engineering, Supply Chain, and R&D.
Performance with compliance: Integrate quality expectations into daily management—without slowing execution.
Practical delivery support: Hands-on help to unblock work, close critical actions, and stabilize operations during change.
FAQs
What does “management and operations” mean in regulated life sciences?
It’s the leadership, routines, plans and systems that keep day-to-day work on track. Production, planning, staffing, training, prioritization, issue management, and performance tracking while maintaining compliance and inspection readiness.
How do operational issues impact GMP compliance?
Execution gaps create quality risk: late investigations, weak CAPAs, uncontrolled changes, incomplete training, and inconsistent records. Operational discipline is often the fastest way to improve compliance outcomes.
Can you help with operational readiness for audits and client visits?
Yes. We help stabilize the fundamentals, improve record discipline, align teams on how the system works, and build a clear operational story backed by evidence.
What are common signs that an organization needs operational support?
Frequent firefighting, missed timelines, unclear ownership, growing backlogs (deviations/CAPAs/change controls), recurring issues, and teams relying on workarounds to keep output moving.
How do you help teams prioritize when everything feels urgent?
We implement lightweight governance: clear goals, risk-based triage, defined owners, time-bound actions, and simple reporting—so leadership can make decisions quickly and teams can execute predictably.
Can you support integration after an acquisition or major transition?
Yes. We help align processes, roles, documentation, and operational rhythms across teams so you can integrate without losing quality control or productivity.
Do you work alongside internal leaders or replace them?
We work alongside your team. The goal is to strengthen your internal capability by building structure, coaching, and helping deliver critical workstreams—so the operation runs smoothly long after the engagement.
How do you balance speed with compliance?
By designing practical processes that fit how work is done, focusing on the controls that matter most, and building a management cadence that catches problems early—before they become deviations or audit findings.
Ready to Strengthen Your Operations?
Whether you’re scaling, integrating a new site, or preparing for a critical milestone, we help you build operational systems that work. Contact us to discuss how we can support your team’s execution and performance.
Terraforme Biosciences 