Site Operations Leader, Sunrise

Job Summary

The Site Leader is responsible for setting the strategic direction and providing overall leadership for the Sunrise manufacturing site, ensuring operational excellence while supporting the organization’s broader business and growth objectives. This role leads the site leadership team and oversees manufacturing operations, manufacturing engineering, process development, sustaining engineering, and warehouse activities.

Through close partnership with functional leaders, the Site Operations Leader ensures alignment and effective execution across key site functions, including quality, supply chain, finance, facilities, and human resources.

The Site Operations Leader is accountable for delivering best-in-class operational performance while ensuring full compliance with all regulatory and corporate requirements. This role fosters a culture of continuous improvement, operational discipline, and talent development to position the Sunrise site as a high-performing, competitive manufacturing operation

Job Details/Responsibilities

Strategic Leadership

• Establish and communicate the strategic vision for the Elkton site aligned with divisional and corporate objectives.
• Build unity at the site and drive a culture reflecting our core values and financial discipline.
• Communicate effectively to the team and stakeholders based on facts and financials.
• Motivate the team on site to achieve a common goal to serving patients and meeting our strategic goals.

Operational Excellence

• Lead the development of a best-in class manufacturing organization utilizing modern manufacturing, engineering, and operational practices.
• Implement continuous improvement initiatives to enhance productivity, quality, service levels, and cost performance.
• Adopt automated tools to drive efficiency of operation and increase accuracy in inspection.
• Accelerate data collection and analysis to drive further improvement in operational efficiencies.

Cross-Functional Leadership

• Provide leadership and oversight for manufacturing and engineering while ensuring effective coordination with quality, supply chain, finance, facilities, Terumo Puerto Rico and human resources.

Performance and Financial Management

• Develop site operating plans, key objectives, and budgets to guide and control operations.
• Monitor performance against goals and ensure achievement of production, cost, and financial targets.

Production and Delivery Execution

• Ensure production schedules and product shipments are executed on time, within budget, and in full compliance with quality and regulatory standards.

Talent Development and Organizational Leadership

• Build, develop, and lead a high-performing leadership team.
• Ensure effective recruitment, development, and succession planning to support long-term organizational capability.

Operational Planning and Forecasting

• Execute manufacturing strategies aligned with demand forecasts and business requirements.
• Analyze operational performance and implement corrective actions to ensure achievement of manufacturing and financial objectives.

Regulatory and Compliance Oversight

• Ensure full compliance with Terumo policies and procedures as well as all applicable FDA, ISO, GMP, and other regulatory requirements.

Capacity and Growth Planning

• Anticipate and plan for future capacity needs to support growth, product transfers, and potential mergers or acquisitions.
• Evaluate expansion opportunities, including facility expansion or new site build.

External and Regulatory Engagement

• Ensure site operations remain in full compliance with federal, state, and local regulatory authorities and maintain effective relationships with relevant agencies.

Additional Responsibilities

• Perform other duties consistent with the leadership and management of a large, regulated manufacturing site.
• Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.

Knowledge, Skills and Abilities (KSA)

• Demonstrated leadership capability to set strategic direction, inspire teams, and deliver results through others.
• Strong interpersonal and influencing skills with the ability to coach, develop talent, and foster high-performing teams.
• Excellent verbal, written, listening, and presentation communication skills.
• Proven ability to lead organizational change, communicate effectively, and drive adoption of new processes or initiatives.
• Strong cross-functional collaboration skills with the ability to partner effectively across manufacturing, engineering, quality, supply chain, and commercial teams.
• Sound judgment and decision-making capability, including the ability to make timely decisions with incomplete information.
• Strong critical thinking, analytical, and problem-solving skills.
• Demonstrated project and operational leadership with the ability to prioritize initiatives and execute effectively.
• Ability to drive accountability and performance while creating a culture of urgency, ownership, and continuous improvement.
• Working knowledge of medical device regulatory and quality systems requirements, including FDA, GMP, ISO, and related standards.
• Financial acumen with the ability to manage budgets and drive cost-effective operational performance.
• Proficiency with standard business software including Microsoft Office (Word, Excel, PowerPoint, Outlook).

Qualifications/ Background Experiences

• Bachelor’s degree in Engineering, Natural Sciences, or Business Administration required; advanced degree preferred, or equivalent combination of education and experience.
• Minimum 15 years of progressive experience in manufacturing, manufacturing engineering, or operations leadership required.
• Minimum 10 years of leadership experience managing manufacturing or engineering teams in a regulated environment.
• Experience within the medical device, pharmaceutical, or similarly regulated industry strongly preferred.
• Demonstrated experience leading multi-disciplinary teams across manufacturing, engineering, etc.
• Experience managing operational budgets and driving operational performance improvements.
• Proven track record of delivering results on schedule and within budget in a complex manufacturing environment.