Director of US Operations

Responsibilities

• 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
• Define, implement, and own the site-level KPI framework spanning safety, quality, delivery, efficiency, and people
• Lead root cause analysis and corrective action processes for recurring performance gaps; hold the team accountable to closure timelines
• Promote 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
• Support NPI in transition roadmap from development and pilot-scale manufacturing to full commercial production, including capacity modeling and resource planning
• 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
• Lead client relationships, providing transparency into site capabilities, risks, and performance
• 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
• 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
• 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

Qualifications

• Proven track record of leading operations teams in complex, high-growth environments
• Experience in medical device manufacturing, quality assurance, and regulatory compliance
• Strong understanding of lean manufacturing principles and ability to apply them in a CDMO setting
• Excellent interpersonal and leadership skills, with the ability to foster a collaborative and results-oriented team culture
• Ability to manage multiple priorities and deadlines in a fast-paced, dynamic environment
• Strong analytical and problem-solving skills, with the ability to drive process improvements and root cause analysis
• Experience with project management tools and techniques, such as Gantt charts and Agile methodologies
• Knowledge of financial management and budgeting practices relevant to a manufacturing environment
• Ability to communicate effectively with cross-functional stakeholders, including sales, engineering, and quality teams

Skills

• Leadership and management skills
• Project management and planning skills
• Financial management and budgeting skills
• Quality assurance and regulatory compliance knowledge
• Lean manufacturing and operational excellence methodologies
• Team building and collaboration skills
• Client relationship management skills

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!!!