Associate Director of Operations

8 Days Old

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.
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Location:
Atlanta

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