Director, Operations Strategy

Job Summary

Serves as the strategic operating partner to the Site Leader for a single-site Class III medical-device manufacturing operation of approximately 300 employees. Defines and executes short-, mid-, and long-term operational priorities and integrates site strategy across capacity, quality, safety, delivery, cost, workforce planning, and operational excellence through cross-functional influence.

Responsibilities

• Develop and maintain the site strategic roadmap and operating plan; translate enterprise and business-unit objectives into site priorities, initiatives, milestones, and measurable outcomes, and support annual and long-range planning cycles.
• Develop mid- and long-term capacity and resource strategies across labor, equipment, facilities, and capital; identify future constraints, capability gaps, investment needs, and required trade-offs in partnership with Finance and functional leaders.
• Establish and sustain an integrated site performance-management and governance process; monitor key indicators for safety, quality, delivery, cost, productivity, and capacity, and provide analyses and recommendations to support executive decisions.
• Serve as a key advisor and member of the site leadership team; help manage leadership cadence, operating reviews, and strategic forums while driving alignment, timely decision-making, cross-functional issue resolution, and accountability.
• Lead site competitiveness, scalability, and transformation initiatives involving efficiency, quality, cost, digitization, automation, and operational excellence; develop business cases, resource plans, milestones, and success measures.
• Partner with Quality and Environmental Health and Safety leaders to integrate quality, safety, regulatory compliance, inspection and audit readiness, and business-continuity considerations into site strategy and operating plans.
• Track execution of the three- to five-year site roadmap, strategic initiatives, and capital priorities; identify risks and dependencies, establish mitigation plans, balance near-term performance with long-term capability, and escalate material issues to site leadership.

Knowledge, Skills and Abilities

• Strong strategic-planning, business-planning, operational-governance, and site-performance-management capabilities.
• Advanced analytical and financial skills, including the ability to evaluate capacity, resources, capital requirements, performance trends, risks, dependencies, and business trade-offs.
• Demonstrated ability to lead complex cross-functional initiatives and influence decisions without direct authority.
• Strong knowledge of regulated manufacturing operations, preferably Class II or Class III medical-device manufacturing.
• Excellent executive communication, facilitation, presentation, and stakeholder-management skills.
• Ability to develop business cases, define milestones and success measures, prioritize resources, and drive accountability for strategic initiatives.
• Knowledge of capacity modeling, workforce and network planning, capital planning, operational excellence, digitization, automation, and transformation practices.
• Understanding of FDA Quality System Regulation, ISO 13485, and global medical-device regulatory requirements is preferred.
• Lean Six Sigma or an equivalent operational-excellence credential is preferred.

Qualifications/Background Experiences

• Bachelor's degree in Engineering, Operations Management, Supply Chain, Business, or a related field.
• At least 10 years of leadership experience in medical-device, pharmaceutical, biotechnology, or another highly regulated manufacturing environment.
• Experience in operations strategy, manufacturing leadership, business planning, operational excellence, project management, or transformation.
• Experience in Class II or Class III medical-device manufacturing.
• Demonstrated experience leading across functions through influence and working with senior site leadership.
• Experience supporting a Site Leader, General Manager, plant leadership team, or equivalent senior operating organization is preferred.
• Experience with capacity modeling, network planning, capital planning, and large-scale transformation is preferred.
• An MBA, master's degree in Engineering, or a related advanced degree is preferred.