Plant Director: GMP Manufacturing & Site Lead

Glaukos Corporation; Burlington (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Glaukos Corporation seeks a dynamic Plant Manager, Site Lead in Burlington, MA to direct GMP manufacturing operations across pharma, medical device, and combination products. You will drive safety, quality, regulatory readiness, and continuous improvement while partnering with Quality, Engineering, Regulatory Affairs, R&D, and Commercial teams.

You will shape the site manufacturing strategy, lead a high-performance team, manage budgets, and oversee technology transfers, scale-up, and new product

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 15+ years in regulated manufacturing environments.
• 10+ years manufacturing leadership with site/plant responsibilities.
• Experience leading manufacturing operations for pharma/device/combination products.
• Strong knowledge of FDA regulations, cGMP, 21 CFR Parts 210/211 and 820, ISO 13485.
• Experience leading regulatory inspections and audit readiness.
• Experience with product launches, technology transfers, validation, scale-up.
• Knowledge of CAPA, deviation management, risk management, validation programs.
• Lean Manufacturing, Six Sigma, operational excellence, continuous improvement.
• Proven ability to develop high-performing teams and drive change.
• Experience with cleanroom/aseptic/sterile or high-volume production desirable.
• Executive presence and ability to influence across organization.

Responsibilities

• Provide strategic and operational leadership for pharmaceutical, medical device, and combination product manufacturing operations.
• Lead manufacturing activities across formulation, fill-finish, sterile processing, device assembly, packaging, labeling.
• Foster a culture where safety, quality, compliance, and operational execution guide daily decisions.
• Ensure compliance with FDA, ISO, cGMP, OSHA, environmental and other regulatory standards.
• Serve as primary site representative during regulatory inspections, customer audits, and third-party assessments.
• Drive inspection readiness and maintain robust quality systems with QA/QC teams.
• Lead technology transfers, process validations, scale-up, and successful product commercialization.
• Develop and execute integrated manufacturing strategies optimizing capacity, throughput, inventory, and service levels.
• Champion Lean, continuous improvement, and digital transformation to improve efficiency and cost.
• Establish and monitor KPIs across safety, quality, delivery, compliance, productivity, and financial performance.
• Lead and develop a high-performing organization spanning manufacturing, engineering, facilities, and operations.
• Drive talent development, succession planning, and leadership growth.
• Oversee plant budgets, capital investments, facilities, cleanrooms, and utilities.
• Partner with Facilities and Engineering on expansion projects and long-term site strategy.
• Collaborate with R&D to support pilot manufacturing activities and innovation.

Skills

Executive leadership

Regulatory inspections

Lean Manufacturing

Six Sigma

Operational Excellence

Continuous Improvement

Regulatory Compliance

Quality Systems

Technology Transfer

Process Validation

Team Leadership

Strategic Planning

Education

Bachelor's degree

Advanced degree

Job description

Glaukos Corporation seeks a dynamic Plant Manager, Site Lead in Burlington, MA to direct GMP manufacturing operations across pharma, medical device, and combination products. You will drive safety, quality, regulatory readiness, and continuous improvement while partnering with Quality, Engineering, Regulatory Affairs, R&D, and Commercial teams.

You will shape the site manufacturing strategy, lead a high-performance team, manage budgets, and oversee technology transfers, scale-up, and new product