GxP Quality Compliance Lead — Systems & Audits

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

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