Sr. Quality Compliance Manager

Glaukos Corporation; San Clemente (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

Glaukos Corporation seeks a Sr. Quality Compliance Manager to lead the quality compliance strategy for GxP computerized systems across the organization.

You will support global audits and inspections, strengthen quality systems, and foster a culture of quality excellence to enable compliant adoption of emerging technologies. In this role, you will oversee system validation, data integrity, risk management, and lifecycle compliance, leading cross-functional projects that improve processes and

Qualifications

• Bachelor's degree or higher in a related scientific discipline; advanced degrees or certifications are a plus.
• 12+ years experience in Quality Assurance, Regulatory Affairs or related functions in medical devices, pharma, 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 at all levels.

Responsibilities

• Lead quality compliance strategy for GxP computerized systems across the organization.
• Provide quality oversight for system validation, data integrity, risk management, and lifecycle compliance.
• Lead cross-functional projects to improve compliance and deliver business value.
• Drive inspection readiness and support regulatory audits, internal audits, and supplier assessments.
• Utilize metrics and analytics to enhance quality processes and compliance programs.

Skills

GxP knowledge

Quality systems

Regulatory affairs

Audit readiness

Leadership

Data integrity

Education

Bachelor's degree in Quality/Regulatory Affairs/Engineering

Advanced degrees or quality certifications (plus)

Tools

eQMS

LIMS

ERP

PLM

Labeling platforms

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.

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.

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