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.