CorDx
Associate Director of Operations
CorDx - Atlanta, Georgia, United States, 30301
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Overview
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Overview
Associate Director Of Operations
We are seeking an experienced and dynamic Associate Director of Operations to lead and scale our operational functions in a fast-paced, growth-stage IVD manufacturing environment. This senior leadership role is responsible for overseeing end-to-end operational activities, ensuring regulatory compliance, driving continuous improvement, and supporting business expansion objectives. The Associate Director will partner cross-functionally with R&D, Quality, Regulatory, and Commercial teams to align operational strategies with company goals and deliver operational excellence. Key Responsibilities: Operational Leadership: Direct daily operations including manufacturing, inventory management, supply chain, logistics, and process optimization. Develop and implement scalable operational strategies to support growth, quality, compliance, and customer service. Team Leadership: Lead and mentor a high-performing team across Production, QA/QC, Supply Chain, and Engineering. Build a culture of accountability, continuous improvement, and clear goal alignment. Production & Compliance Oversight: Oversee production scheduling, capacity planning, and resource allocation. Ensure adherence to FDA 21 CFR Part 820, ISO 13485, IVDR, and global regulatory standards. Support audits, regulatory inspections, and supplier assessments. Operational Excellence & Improvement: Champion Lean, Six Sigma, and continuous improvement practices to optimize workflows, reduce costs, and enhance product quality. Identify and implement systems, processes, and technologies that improve operational scalability. Financial & Cross-Functional Management: Develop and manage operational budgets and forecasts. Collaborate with R&D, Quality, Regulatory, Finance, and Commercial teams to support business strategy and new product introductions.
We are seeking an experienced and dynamic Associate Director of Operations to lead and scale our operational functions in a fast-paced, growth-stage IVD manufacturing environment. This senior leadership role is responsible for overseeing end-to-end operational activities, ensuring regulatory compliance, driving continuous improvement, and supporting business expansion objectives. The Associate Director will partner cross-functionally with R&D, Quality, Regulatory, and Commercial teams to align operational strategies with company goals and deliver operational excellence. Key Responsibilities: Operational Leadership: Direct daily operations including manufacturing, inventory management, supply chain, logistics, and process optimization. Develop and implement scalable operational strategies to support growth, quality, compliance, and customer service. Team Leadership: Lead and mentor a high-performing team across Production, QA/QC, Supply Chain, and Engineering. Build a culture of accountability, continuous improvement, and clear goal alignment. Production & Compliance Oversight: Oversee production scheduling, capacity planning, and resource allocation. Ensure adherence to FDA 21 CFR Part 820, ISO 13485, IVDR, and global regulatory standards. Support audits, regulatory inspections, and supplier assessments. Operational Excellence & Improvement: Champion Lean, Six Sigma, and continuous improvement practices to optimize workflows, reduce costs, and enhance product quality. Identify and implement systems, processes, and technologies that improve operational scalability. Financial & Cross-Functional Management: Develop and manage operational budgets and forecasts. Collaborate with R&D, Quality, Regulatory, Finance, and Commercial teams to support business strategy and new product introductions.