Biotech Operations Leader: Production, Quality & Compliance

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

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