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.
RequirementsOrganizational 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 strategy into annual operational plans with clear milestones, owners, and success metrics.
- Align site operations with commercial, quality, regulatory, and finance functions to ensure seamless execution of business commitments.
- Lead change management initiatives - communicating context, building buy-in, and sustaining momentum through ambiguity.
- Perform other related duties as assigned by management.
Benefits- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan with Company Match
- Paid Time Off, Personal Days, AND Birthday Holiday!
- Lifetime Membership Subsidy and Wellness Resources
- Life Insurance (Basic, Voluntary & AD&D)
- Family Leave (Maternity, Paternity)
- Short-Term & Long-Term Disability
- Taco Thursdays!!!
