Sr. Quality Compliance Manager

Glaukos Corporation • San Clemente, CA

6d

About The Position

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.

Requirements

• Bachelor's degree in Quality, Regulatory Affairs, Engineering, Software Engineering, or a related scientific discipline.
• 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.

Nice To Haves

• Advanced degrees or quality certifications are a plus.

Responsibilities

• 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.

Benefits

• Opportunity to influence global quality strategy
• Drive meaningful process improvements
• Help ensure the delivery of safe, effective products for patients worldwide

What This Job Offers

• Job Type: Full-time
• Career Level: Senior