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:
UsThis 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.#GKOSUSGenerous. Innovative. Leadership-driven. Family-oriented. Socially responsible. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases. Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases. Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients. Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts. Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations. Full time
Posting Date: 2026-10-03
