Senior Operations Manager

Cordx Inc; Georgia; On-site; USD 110,000 - 180,000; Full time

Job summary

CorDx, a multinational biotech company, is seeking a Senior Operations Manager to drive operational excellence across production, supply chain, and quality in a fast-growing environment. You will lead a multidisciplinary team, enforce regulatory compliance (FDA 21 CFR Part 820, ISO 13485, IVDR), and champion Lean Six Sigma to improve processes and reduce waste.

This role requires a Bachelor's (Master’s preferred), 10+ years in biotech/manufacturing, and a proven record of cross-functional

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related field.
• 10+ years in biotech/diagnostics/medical device manufacturing.
• 5+ years leading cross-functional ops teams.
• Regulatory knowledge of FDA 21 CFR Part 820, ISO 13485, IVDR.
• Proven Lean, Six Sigma or continuous improvement experience.
• Strong budgeting, planning and problem-solving skills.
• Excellent team-building and communication abilities.

Responsibilities

• Oversee day-to-day operations across production, inventory, and logistics.
• Drive efficiency, scalability, and cost-effectiveness across the value chain.
• Lead and mentor operations teams (Production, QA/QC, Supply Chain).
• Ensure compliance with FDA, IVDR, ISO standards.
• Collaborate with R&D, Regulatory, and Commercial teams.
• Manage budgets and identify cost-saving opportunities.

Skills

Regulatory compliance

Lean Six Sigma

Cross-functional leadership

Strategic planning

Education

Bachelor's degree in Engineering / Life Sciences

Master’s or MBA preferred

Tools

ERP systems

Job description

Job Description

About Us

CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-19, pregnancy, drug abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

We’re seeking an experienced Senior Operations Manager for our operations team. This role is key to ensuring operational excellence, regulatory compliance, and seamless cross-functional collaboration in a fast-paced, high-growth environment.

Key Responsibilities:

Operations Management

• Oversee all day-to-day operations, including production, inventory, supply chain, logistics, and process optimization.
• Drive efficiency, scalability, and cost-effectiveness across the value chain.

Team Leadership

• Lead, mentor, and develop a multidisciplinary operations team (Production, QA/QC, Supply Chain).
• Foster a high-performance, accountability-driven culture with clear communication of goals and KPIs.

Production Oversight

• Manage daily and long-term production planning to meet delivery timelines, quality standards, and regulatory requirements.

Regulatory Compliance

• Ensure all operational activities comply with applicable regulations: FDA (21 CFR Part 820), IVDR, ISO 13485, and other global standards in biotech/diagnostic manufacturing.

Continuous Improvement

• Champion Lean, Six Sigma, or similar methodologies to optimize workflows, minimize waste, and enhance product quality.

Cross-Functional Collaboration

• Partner closely with R&D, Quality, Regulatory, Supply Chain, and Commercial teams to align operational strategies with business objectives.

Budget & Cost Management

• Build and manage operational budgets, monitor expenses, and identify cost-saving opportunities while maintaining quality and compliance.

Requirements

• Education: Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or a related field. Master’s or MBA preferred.
• Experience: 10+ years in biotech, diagnostics, or medical device manufacturing, with 5+ years in leadership roles managing cross‑functional operations teams.
• Strong track record of role stability (30+ months average tenure) and career progression, with experience at 7 or fewer companies preferred.
• Regulatory knowledge: Solid understanding of FDA 21 CFR Part 820, ISO 13485, IVDR, and other global quality standards. Proficiency with ERP systems and operating in highly regulated environments.
• Operational & leadership skills: Proven success driving Lean, Six Sigma, or continuous improvement initiatives.
• Strong operational planning, budgeting, and problem-solving capabilities.
• Collaborative leader with excellent team-building, communication, and decision-making skills.
• Preferred Attributes: Resourceful, data-driven, and comfortable in growth-stage or scaling environments.
• Strong business acumen with an operational mindset.

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.