Director, Operations Strategy

Terumo•Davie, FL

About The Position

The Director, Operations Strategy serves as the strategic operating partner to the Site Leader for a single-site Class III medical-device manufacturing operation of approximately 300 employees. The role 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. The Director develops the site strategic roadmap and operating plan, translates enterprise and business-unit objectives into measurable site priorities, and supports annual and long-range planning. The role advises the site leadership team, establishes site performance-management and governance processes, and leads competitiveness, scalability, and transformation initiatives. It also partners with Quality, Environmental Health and Safety, Finance, and functional leaders to incorporate resource planning, regulatory readiness, risk mitigation, and long-term capability needs into site strategy. The incumbent must follow established Environmental Health & Safety and Quality System policies, programs, rules, and practices, including those relating to product and patient safety, associate health and safety, and the environment and community.

Requirements

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.
Strong strategic-planning, business-planning, operational-governance, and site-performance-management capabilities.
Advanced analytical and financial skills, including evaluating 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.

Nice To Haves

Understanding of FDA Quality System Regulation, ISO 13485, and global medical-device regulatory requirements.
Lean Six Sigma or an equivalent operational-excellence credential.
Experience supporting a Site Leader, General Manager, plant leadership team, or equivalent senior operating organization.
Experience with capacity modeling, network planning, capital planning, and large-scale transformation.
An MBA, master’s degree in Engineering, or a related advanced degree.

Responsibilities

Develop and maintain the site strategic roadmap and operating plan, translating enterprise and business-unit objectives into site priorities, initiatives, milestones, and measurable outcomes; support annual and long-range planning cycles.
Develop mid- and long-term capacity and resource strategies across labor, equipment, facilities, and capital, identifying future constraints, capability gaps, investment needs, and trade-offs with Finance and functional leaders.
Establish and sustain an integrated site performance-management and governance process; monitor safety, quality, delivery, cost, productivity, and capacity indicators and provide analyses and recommendations for executive decisions.
Serve as a key advisor and member of the site leadership team; support leadership cadence, operating reviews, and strategic forums while driving alignment, timely decisions, 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 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.
Follow established Environmental Health & Safety and Quality System policies, programs, rules, and practices, including requirements related to product and patient safety, associate health and safety, and the environment and community.