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Sr. Quality Compliance Manager

Glaukos
Posted 25 days ago, valid for 11 days
Location

San Clemente, CA, US

Salary

$130,300 - $162,900 per year

Contract type

Full Time

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Sonic Summary

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  • The Sr. Quality Compliance Manager will lead the quality compliance strategy for GxP computerized systems, ensuring regulatory compliance and promoting continuous improvement.
  • Candidates should have a Bachelor's degree in Quality, Regulatory Affairs, Engineering, Software Engineering, or a related scientific discipline, with at least 12 years of experience in relevant fields.
  • The role requires expertise in GxP systems, computer system assurance, validation, and data integrity, along with the ability to lead complex initiatives and influence stakeholders.
  • The position is based at Glaukos Corporation, a mission-driven company focused on innovative vision care solutions, and offers a competitive salary.
  • Glaukos is an equal opportunity employer, and all employment offers are contingent upon successful background checks and drug screenings.

Sr. Quality Compliance Manager (Quality Compliance Lead)

How will you make an impact?

Lead quality compliance strategy for GxP computerized systems across the organization, ensuring regulatory compliance, driving continuous improvement, and enabling the compliant adoption of emerging technologies. You will play a key role in strengthening quality systems, supporting global audits and inspections, and fostering a culture of quality excellence.

What will you do?

  • Serve as the Quality Compliance subject matter expert for GxP computerized systems, including eQMS, LIMS, ERP, PLM, and labeling platforms.
  • Provide quality oversight for system validation, data integrity, risk management, and compliance throughout the system lifecycle.
  • Lead cross-functional projects that improve compliance, optimize processes, and deliver business value.
  • Drive inspection readiness and support regulatory audits, internal audits, and supplier assessments.
  • Utilize metrics, analytics, and emerging technologies to enhance quality processes and compliance programs.

How will you get here?

  • Bachelor's degree in Quality, Regulatory Affairs, Engineering, Software Engineering, or a related scientific discipline. Advanced degrees or quality certifications are a plus.
  • 12+ years of experience in Quality Assurance, Regulatory Affairs, or related functions within medical devices, pharmaceuticals, biologics, or combination products.
  • Strong knowledge of GxP systems, computer system assurance/validation, data integrity, and global regulatory requirements.
  • Experience partnering across Quality, Operations, R&D, IT, and Digital Quality teams.
  • Proven ability to lead complex initiatives, influence stakeholders, and communicate effectively at all levels.

Why Glaukos?

Join a mission-driven organization transforming vision care through innovation. You'll have the opportunity to influence global quality strategy, drive meaningful process improvements, and help ensure the delivery of safe, effective products for patients worldwide.

#GKOSUS


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. 


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.




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By applying, a Glaukos account will be created for you. Glaukos's Privacy Policy and Terms & Conditions will apply.

SonicJobs' Terms & Conditions and Privacy Policy also apply.