Glaukos Corporation
Principal Quality Engineer - Pharma Development
Glaukos Corporation, Aliso Viejo, California, United States, 92656
Job Description
Principal Quality Engineer - Pharma Development (Aliso Viejo, CA or Burlington, MA)
How Will You Make An Impact?
Glaukos is seeking a
Principal Quality Engineer - Pharma Development
with expertise in drug/device combination products. This role will lead implementation of quality strategy and oversee GMP compliance to ensure effective operations across R&D, Applied Research, Regulatory Affairs, and CMOs. The Principal Quality Engineer will serve as the Quality liaison for all QA matters, supporting both clinical and commercial development.
This is an opportunity to shape quality systems in a growing organization developing innovative combination products. You will collaborate with top-tier teams and CMOs, influencing quality at every stage of development.
What Will You Do? Act as GMP Quality Subject Matter Expert for assigned drug programs. Oversee quality aspects of pharmaceutical development in outsourced environments for drug substance, drug product, and clinical trial materials. Review and approve validation protocols/reports, specifications, batch records, and product releases. Ensure compliance with quality systems (change control, deviations, complaints, training, etc.). Provide QC review of documents supporting regulatory submissions (CMC, IND, NDA, etc.). Conduct or participate in audits of internal teams and external partners. Represent Quality on cross-functional project teams and support process improvements. Support special projects and departmental objectives as needed. Provide backup support to QA colleagues when required. How Will You Get Here?
Education & Experience:
12+ years of industry experience, or 8+ years with a Master's degree. Strong background in pharmaceutical development and combination products.
Technical Expertise:
In-depth knowledge of GMP, FDA/EMA/ICH guidelines, and validation practices. Familiarity with CMC regulatory filings (USA, EU, global). Working knowledge of technical/analytical aspects of pharmaceutical manufacturing.
Skills & Abilities:
Proven project management and cross-functional leadership. Strong oral and written communication skills. Ability to exercise sound judgment and handle complex situations independently. Audit management experience preferred.
#GKOSUS
About Us
Generous. 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.
Principal Quality Engineer - Pharma Development (Aliso Viejo, CA or Burlington, MA)
How Will You Make An Impact?
Glaukos is seeking a
Principal Quality Engineer - Pharma Development
with expertise in drug/device combination products. This role will lead implementation of quality strategy and oversee GMP compliance to ensure effective operations across R&D, Applied Research, Regulatory Affairs, and CMOs. The Principal Quality Engineer will serve as the Quality liaison for all QA matters, supporting both clinical and commercial development.
This is an opportunity to shape quality systems in a growing organization developing innovative combination products. You will collaborate with top-tier teams and CMOs, influencing quality at every stage of development.
What Will You Do? Act as GMP Quality Subject Matter Expert for assigned drug programs. Oversee quality aspects of pharmaceutical development in outsourced environments for drug substance, drug product, and clinical trial materials. Review and approve validation protocols/reports, specifications, batch records, and product releases. Ensure compliance with quality systems (change control, deviations, complaints, training, etc.). Provide QC review of documents supporting regulatory submissions (CMC, IND, NDA, etc.). Conduct or participate in audits of internal teams and external partners. Represent Quality on cross-functional project teams and support process improvements. Support special projects and departmental objectives as needed. Provide backup support to QA colleagues when required. How Will You Get Here?
Education & Experience:
12+ years of industry experience, or 8+ years with a Master's degree. Strong background in pharmaceutical development and combination products.
Technical Expertise:
In-depth knowledge of GMP, FDA/EMA/ICH guidelines, and validation practices. Familiarity with CMC regulatory filings (USA, EU, global). Working knowledge of technical/analytical aspects of pharmaceutical manufacturing.
Skills & Abilities:
Proven project management and cross-functional leadership. Strong oral and written communication skills. Ability to exercise sound judgment and handle complex situations independently. Audit management experience preferred.
#GKOSUS
About Us
Generous. 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.