Director of US Operations

The Director of US Operations is a senior leadership role responsible for the end-to-end operational performance of Nextern’s US medical device contract development and manufacturing organization (CDMO) site. This individual owns site P&L accountability, leads a cross-functional operations team, and serves as the primary architect of organizational structure, operating cadence, and commercial delivery. The Director of US Operations plays a critical role in translating business growth into disciplined execution — building the systems, teams, and culture required to scale from development-phase production to high-volume commercial manufacturing while sustaining the quality, delivery, and cost performance expected by world-class medical device clients.

Organizational Design & Leadership

• Design and build a scalable site organizational structure aligned to growth stage, client commitments, and regulatory requirements.
• Recruit, develop, and retain high-performing operations leaders across manufacturing, supply chain, quality operations, engineering, and facilities.
• Establish clear roles, accountabilities, and decision rights across all operational functions.
• Foster a culture of transparency, urgency, and continuous improvement consistent with a fast-paced CDMO environment.
• Drive alignment between site operations and corporate strategy through structured communication and cascaded goal-setting.

Operational Excellence & Metrics

• Define, implement, and own the site-level KPI framework spanning safety, quality, delivery, efficiency, and people.
• Establish a rigorous operational review cadence — daily tier meetings, weekly ops reviews, monthly leadership scorecards — to drive data-driven decisions.
• Lead root cause analysis and corrective action processes for recurring performance gaps; hold the team accountable to closure timelines.
• Champion lean manufacturing and operational excellence methodologies (e.g., Kaizen, VSM, 5S) to eliminate waste and reduce variability.
• Benchmark site performance against industry standards and drive continuous improvement to close gaps.

Commercial Scale & Capacity Planning

• Support NPI in transition roadmap from development and pilot-scale manufacturing to full commercial production, including capacity modeling and resource planning.
• Partner with Business Development and Program Management to translate client pipeline into operational readiness plans in partnership with NPI.
• Lead capital expenditure planning, equipment acquisition, and facility expansion initiatives required to support commercial commitments.
• Develop and maintain a 12- to 36-month capacity plan that balances client demand, regulatory timelines, and financial constraints.
• Serve as a senior operational point of contact for key client relationships, providing transparency into site capabilities, risks, and performance.

Quality & Regulatory Compliance

• Ensure the site operates in full compliance with 21 CFR Part 820, ISO 13485, and applicable international regulatory frameworks.
• Partner with Quality leadership to maintain a state of continuous inspection readiness; lead site responses to FDA, notified body, and client audits.
• Embed quality ownership at the operations level — reinforcing the principle that quality is built in, not inspected in.

Financial & Business Performance

• Own the site operating budget, headcount plan, and capital budget; deliver financial commitments with discipline and accountability.
• Identify and execute cost reduction and productivity improvement initiatives that improve site margin without compromising quality or delivery.
• Provide accurate operational forecasts and variance analysis to senior leadership on a regular cadence.

Strategy Execution & Cross-Functional Alignment

• Translate multi-year business…