Job Description

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.

Requirements

Education:

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or a related field required.
• Master’s degree or MBA preferred.

Professional Experience:

• 10+ years of operational leadership in biotech, diagnostics, or medical device manufacturing.
• 5+ years in senior management roles, leading cross-functional teams.
• Experience in growth-stage or scaling environments preferred.

Regulatory & Operational Expertise:

• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IVDR, and global quality standards.
• Hands-on experience with regulatory audits, inspections, and operational risk management.
• Proficiency with ERP and production planning systems.

Leadership & Business Skills:

• Proven ability to build and develop high-performing teams.
• Strong skills in operational planning, budgeting, and data-driven decision-making.
• Experience leading Lean or continuous improvement initiatives.

Preferred Attributes:

• Resourceful, results-driven, and effective in fast-paced, regulated environments.
• Strong business acumen and operational insight.
• Global or multi-site manufacturing experience a plus.

Benefits

• Highly competitive compensation package.
• Comprehensive medical, dental, and vision insurance.
• 401(k) plan with generous company contributions.
• Flexible paid time off (PTO) policy.
• Additional substantial benefits.

Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

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