Director Site Operations

Director of Site Operations

Full time / Permanent

Durham, CT & Wallingford, CT

Job Overview:

We are seeking an experienced Director of Site Operations to oversee the operational functions at our two manufacturing facilities in Connecticut. This role will lead and manage all aspects of site operations, including production, quality assurance, supply chain management, and workforce development. The ideal candidate will have a strong background in med-tech manufacturing, a deep understanding of regulatory requirements, and proven leadership experience in a fast-paced, results-driven environment.

Key Responsibilities:

• Lead and manage daily site operations for contract manufacturing, ensuring efficient, cost-effective, and timely production of high-quality medical devices.
• Direct, mentor, and develop teams across various departments (production, quality assurance, maintenance, logistics, etc.) to ensure operational excellence.
• Drive operational improvements and implement best practices to enhance productivity, reduce costs, and improve throughput.
• Ensure compliance with all applicable regulations, including FDA, ISO, and GMP standards, to maintain the highest quality and safety standards.
• Oversee site audits (internal and external), inspections, and certifications required for medical device manufacturing.
• Work closely with quality teams to manage risk, control deviations, and ensure product integrity.
• Continuously evaluate operational performance and identify opportunities for process improvement, efficiency gains, and cost reduction.
• Develop and monitor key performance indicators (KPIs) to track production, quality, and delivery performance.
• Manage business unit budget, forecasts, and capital investment planning to ensure optimal resource allocation and cost management.
• Oversee the supply chain function to ensure the timely procurement and availability of materials for production.
• Collaborate with procurement and logistics teams to ensure efficient inventory management and on-time delivery of products.
• Collaborate with senior leadership and cross-functional teams (engineering, R&D, sales, etc.) to ensure alignment with organizational goals and objectives.
• Participate in the development and execution of the site’s strategic plan, ensuring the facility’s capabilities align with customer needs and market demands.
• Partner with other departments to ensure seamless integration of new products into the manufacturing process.
• Champion a strong safety culture and ensure compliance with health, safety, and environmental regulations.
• Proactively address any safety concerns and ensure that the site maintains a safe working environment for all employees.

Qualifications:

• Bachelor's degree in Engineering, Manufacturing, Operations Management, or a related field. A Master's degree is a plus.
• Minimum of 10 years of experience in operations or manufacturing leadership roles, with at least 5 years in the med-tech or pharmaceutical industry.
• Proven experience managing large teams, overseeing production schedules, and driving operational efficiency in a regulated environment.
• Expertise in quality systems, regulatory compliance, and industry standards (FDA, ISO, GMP, etc.).
• Strong financial acumen, including budget management and cost control.
• Exceptional leadership and team management skills, with the ability to motivate and guide teams to achieve operational goals.
• Strong problem-solving abilities and a continuous improvement mindset.
• Excellent communication and interpersonal skills, capable of working effectively with internal teams, senior leadership, and external stakeholders.
• Ability to manage multiple priorities in a fast-paced environment while maintaining high standards of quality and compliance.
• Knowledge of ERP systems, manufacturing execution systems (MES), and other relevant technologies.