SpyGlass Pharma, Inc. · 5 hours ago
Senior Manager, Quality
Aliso Viejo, CA
Full-time
Onsite
Senior Level, Lead/Staff
$160K/yr - $180K/yr
10+ years expSpyGlass Pharma is focused on improving and preserving the vision of patients suffering from chronic eye conditions. The Sr. Manager of Quality is responsible for supporting the Pre-Approval Inspection Readiness Program, ensuring compliance with regulatory expectations for commercial manufacturing.
DeliveryMedicalPharmaceutical
Responsibilities
Maintain expert knowledge of FDA, USP, cGMP, and other quality system standards and regulations, applying these to SpyGlass Pharma’s operations
Accountable for execution of QMS Gap Assessment Activities
Manage consultants supporting PAI Readiness Activities and work as a liaison between SpyGlass and contract manufacturers
Point of contact for functional team remediation activities
Lead and coordinate successful gap remediation activities at both SpyGlass and contract manufacturers
Identify risks and resolve QMS issues and appropriately communicate gating items to senior management and stakeholders
Assist in the development and revision of SOPs and controlled documents to support GxP-regulated activities. This includes building a robust QMS supporting PAI and commercial manufacturing
Ensure the QMS documentation effectively supports system functionality and product quality
Coordinate GxP pre-approval inspection preparation activities for SpyGlass filings/products in support of regulatory filings
Influence and train inspection preparation functional teams before and during audits
Facilitate responses to health authority findings to ensure the corrective actions are robust, reviewed by appropriate leadership and submitted on time. This includes tracking all commitments to timely closure
Strategize corrective action plans and provide compliance support during implementation to ensure successful inspections
Provide hands-on support for functional teams with procedural writing, workflow management, and record uploads
Contribute to cross-functional teams focused on continuous improvement of quality system processes
Support post approval activities such as FDA field alerts, product recalls and withdrawals
Complete Annual Product Reviews and ensure product quality and compliance
Qualification
Required
Bachelor's degree in scientific discipline or equivalent experience
Minimum of 10 years of progressive experience in the biotechnology or pharmaceutical industry
Experience with FDA PAI readiness and PAI audits both front and back-room support is a must
Knowledge of pharmaceutical quality and learning management systems
Working knowledge of product development processes and systems. This includes Pharmaceutical, Medical Devices and/or Clinical Operations
High level of professionalism and ability to collaborate effectively in dynamic team environments
Strong judgment and ability to work independently with minimal supervision
Ability to manage tasks with competing priorities and deadlines
Proficient in implementing written and verbal instructions at all organizational levels
Technical expertise in Microsoft Office (Outlook, Word, Excel, PowerPoint)
Alignment with SpyGlass Pharma's culture and values
Willingness to travel 10-15% (both domestic and international)
Preferred
Qualified Auditor Certification preferred
Benefits
Share in our success with stock options, giving you a stake in the company’s future.
Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
Generous paid time off, including holidays, vacation days, and personal leave.
Company
SpyGlass Pharma, Inc.
SpyGlass Pharma was Co-founded by Dr. Malik Y. Kahook, MD and Glenn Sussman.
11-50 employees
H1B Sponsorship
SpyGlass Pharma, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
Funding
Current Stage
Late StageTotal Funding
$184.78MKey Investors
Sands Capital VenturesRA Capital Management
2025-06-02Series D· $75M
2023-07-10Series C· $90M
2021-01-04Series Unknown· $13.75M
Leadership Team
Patrick Mooney
Chief Executive Officer
Glenn Sussman
Co-Founder and CTO
Recent News
2026-02-04
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Company data provided by crunchbase