Glaukos

Sr. Quality Compliance Manager

Glaukos • $120K — $145K *
San Clemente, CA 92672In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Quality, Regulatory Affairs, Engineering, Software Engineering, or a related field
  • 12+ years of experience in Quality Assurance or Regulatory Affairs in medical devices, pharmaceuticals, biologics, or combination products
  • Deep understanding of GxP systems and computer system assurance
  • Experience with data integrity and global regulatory requirements
  • Skilled at cross-functional collaboration with Quality, Operations, R&D, IT, and Digital Quality teams
  • Proven leadership in executing complex initiatives and engaging with stakeholders effectively

Responsibilities

  • Lead the quality compliance strategy for GxP computerized systems
  • Serve as the subject matter expert for quality compliance across various electronic systems
  • Provide oversight on system validation and compliance during the system lifecycle
  • Drive initiatives to improve compliance and optimize operational processes
  • Prepare for inspections and audits, offering support for regulatory, internal, and supplier assessments
  • Leverage metrics and analytics to enhance quality processes

Benefits

  • Opportunities for professional development
  • Collaborative work environment
  • Access to emerging technologies
  • Engagement in continuous improvement initiatives
  • Strong emphasis on quality excellence culture
Full Job Description
Job Description

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.

#GKOSUS

About Glaukos

Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company's second-generation MIGS device, the iStent inject, was approved by the FDA in June 2018. Glaukos is also developing a pipeline of innovative technologies in corneal health, including the recently acquired Microline surgical platform, as well as novel drug delivery technologies.
Learn more about Glaukos
Size
727 employees
Market Cap
$1.9 billion
Industry
Healthcare
Net Income
-$120.3 million
Founded
1998
5 Year Trend
+20.8%
Revenue
$224.9 million
NASDAQ
GKOS
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Glaukos

More Pharmaceuticals & Biotech Jobs

Find similar Sr. Quality Compliance Manager jobs:

NationwideSan Clemente, CA