What are the responsibilities and job description for the Plant Manager, Site Lead - Burlington position at Glaukos Corporation?
Glaukos - Plant Manager, Site Lead (Burlington, MA)
Lead Manufacturing Excellence for a Growing Global Organization
We are seeking an experienced and strategic Plant Manager, Site Lead to oversee all manufacturing and site operations at a GMP-compliant facility supporting pharmaceutical, medical device, and combination products. This executive leadership role is accountable for driving operational excellence across production, quality, engineering, facilities, and safety while ensuring the consistent delivery of high-quality products that improve patient outcomes.
As the senior leader for the site, you will establish and execute the manufacturing strategy, foster a culture of safety, quality, and continuous improvement, and ensure readiness for regulatory inspections, product launches, and future growth. You will partner closely with leaders across Quality, Engineering, Supply Chain, Regulatory Affairs, R&D, and Commercial functions to deliver business objectives while maintaining compliance with global regulatory requirements.
What You'll Do
- 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, and related operations.
- Foster a culture where safety, quality, compliance, and operational execution are foundational to daily decision-making.
- Ensure compliance with FDA, ISO, cGMP, OSHA, environmental, and other applicable regulatory standards.
- Serve as the primary site representative during regulatory inspections, customer audits, and third-party assessments.
- Drive inspection readiness and maintain robust quality systems through close partnership with Quality Assurance and Quality Control teams.
- Lead technology transfers, process validations, scale-up activities, and the successful commercialization of new products.
- Develop and execute integrated manufacturing strategies that optimize capacity, throughput, inventory, and service levels while supporting business growth.
- Champion Lean Manufacturing, continuous improvement, operational excellence, and digital transformation initiatives to improve efficiency, quality, and cost performance.
- Establish and monitor key performance indicators across safety, quality, delivery, compliance, productivity, and financial performance.
- Lead and develop a high-performing organization spanning manufacturing, engineering, facilities, and operational support functions.
- Drive talent development, succession planning, employee engagement, and leadership growth throughout the organization.
- Oversee plant budgets, capital investments, facility operations, cleanroom environments, utilities, and infrastructure supporting sterile and cGMP manufacturing.
- Partner with Facilities and Engineering teams to support expansion projects, equipment investments, and long-term site strategy.
- Collaborate with R&D teams to support pilot manufacturing activities, technology development, and innovation initiatives.
What You'll Bring
- Bachelor's degree required; advanced degree preferred.
- 15 years of experience within pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
- 10 years of progressive manufacturing leadership experience, including senior site or plant leadership responsibilities.
- Proven success leading complex manufacturing operations supporting pharmaceuticals, medical devices, combination products, biotechnology, or similarly sophisticated production environments.
- Strong knowledge of FDA regulations, cGMP requirements, 21 CFR Parts 210/211 and 820, ISO 13485, and global quality standards.
- Demonstrated experience leading regulatory inspections, maintaining audit readiness, and operating within highly compliant environments.
- Experience supporting product launches, technology transfers, process validation, and scale-up from development through commercial production.
- Strong understanding of quality systems, CAPA, deviation management, risk management, and validation programs.
- Expertise in Lean Manufacturing, Six Sigma, operational excellence, and continuous improvement methodologies.
- Proven ability to develop high-performing teams, lead organizational change, and drive sustainable business results.
- Experience managing cleanroom, aseptic, sterile manufacturing, or high-volume production environments is highly desirable.
- Strong executive presence, business acumen, and the ability to influence across all levels of the organization.
Why Join Us
This is an opportunity to shape the future of a growing manufacturing organization by leading a complex, highly regulated operation that directly supports the delivery of innovative therapies and technologies. You will play a critical role in advancing manufacturing capabilities, developing talent, driving operational excellence, and contributing to products that positively impact patients around the world.
#GKOSUS
Lead Manufacturing Excellence for a Growing Global Organization
We are seeking an experienced and strategic Plant Manager, Site Lead to oversee all manufacturing and site operations at a GMP-compliant facility supporting pharmaceutical, medical device, and combination products. This executive leadership role is accountable for driving operational excellence across production, quality, engineering, facilities, and safety while ensuring the consistent delivery of high-quality products that improve patient outcomes.
As the senior leader for the site, you will establish and execute the manufacturing strategy, foster a culture of safety, quality, and continuous improvement, and ensure readiness for regulatory inspections, product launches, and future growth. You will partner closely with leaders across Quality, Engineering, Supply Chain, Regulatory Affairs, R&D, and Commercial functions to deliver business objectives while maintaining compliance with global regulatory requirements.
What You'll Do
- 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, and related operations.
- Foster a culture where safety, quality, compliance, and operational execution are foundational to daily decision-making.
- Ensure compliance with FDA, ISO, cGMP, OSHA, environmental, and other applicable regulatory standards.
- Serve as the primary site representative during regulatory inspections, customer audits, and third-party assessments.
- Drive inspection readiness and maintain robust quality systems through close partnership with Quality Assurance and Quality Control teams.
- Lead technology transfers, process validations, scale-up activities, and the successful commercialization of new products.
- Develop and execute integrated manufacturing strategies that optimize capacity, throughput, inventory, and service levels while supporting business growth.
- Champion Lean Manufacturing, continuous improvement, operational excellence, and digital transformation initiatives to improve efficiency, quality, and cost performance.
- Establish and monitor key performance indicators across safety, quality, delivery, compliance, productivity, and financial performance.
- Lead and develop a high-performing organization spanning manufacturing, engineering, facilities, and operational support functions.
- Drive talent development, succession planning, employee engagement, and leadership growth throughout the organization.
- Oversee plant budgets, capital investments, facility operations, cleanroom environments, utilities, and infrastructure supporting sterile and cGMP manufacturing.
- Partner with Facilities and Engineering teams to support expansion projects, equipment investments, and long-term site strategy.
- Collaborate with R&D teams to support pilot manufacturing activities, technology development, and innovation initiatives.
What You'll Bring
- Bachelor's degree required; advanced degree preferred.
- 15 years of experience within pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
- 10 years of progressive manufacturing leadership experience, including senior site or plant leadership responsibilities.
- Proven success leading complex manufacturing operations supporting pharmaceuticals, medical devices, combination products, biotechnology, or similarly sophisticated production environments.
- Strong knowledge of FDA regulations, cGMP requirements, 21 CFR Parts 210/211 and 820, ISO 13485, and global quality standards.
- Demonstrated experience leading regulatory inspections, maintaining audit readiness, and operating within highly compliant environments.
- Experience supporting product launches, technology transfers, process validation, and scale-up from development through commercial production.
- Strong understanding of quality systems, CAPA, deviation management, risk management, and validation programs.
- Expertise in Lean Manufacturing, Six Sigma, operational excellence, and continuous improvement methodologies.
- Proven ability to develop high-performing teams, lead organizational change, and drive sustainable business results.
- Experience managing cleanroom, aseptic, sterile manufacturing, or high-volume production environments is highly desirable.
- Strong executive presence, business acumen, and the ability to influence across all levels of the organization.
Why Join Us
This is an opportunity to shape the future of a growing manufacturing organization by leading a complex, highly regulated operation that directly supports the delivery of innovative therapies and technologies. You will play a critical role in advancing manufacturing capabilities, developing talent, driving operational excellence, and contributing to products that positively impact patients around the world.
#GKOSUS