Director, Quality Compliance

About Spy Glass Pharma:

At Spy Glass Pharma (NASDAQ: SGP), we are focused on improving and preserving the vision of patients living with chronic eye diseases, while minimizing the burden treatment can place on their daily lives. We are advancing innovative long-term ophthalmic drug delivery technologies designed to provide sustained therapy through cataract surgery and help improve patient outcomes.

We have built a highly collaborative team with deep expertise across ophthalmology, drug delivery, pharmaceuticals, and medical devices. Our scientists, engineers, and clinical leaders bring decades of experience developing and commercializing breakthrough technologies, united by a shared commitment to patients and our guiding principle: “We create for patients.” That mindset shapes how we build our products, our teams, and our culture.

Backed by strong clinical progress, significant funding, and a growing organization, Spy Glass Pharma is entering an exciting stage of growth as we advance our lead program, the Spy Glass BIM-IOL, through Phase 3 clinical development.

We are seeking a Director of Quality Compliance to join our team at Spy Glass Pharma. This role will be responsible for establishing, maintaining, and overseeing the global Quality Management System (QMS) compliance framework for pharmaceutical & drug-device combination products. This role drives internal and external lifecycle compliance monitoring, manages the corporate audit program and leads risk-based auditing, and leads inspection readiness across internal sites and external partners (CMOs, CROs, and device component suppliers).

This role leads and develops a team that ensures consistent, high‑quality audit execution across Spy Glass Pharma’s global manufacturing and supply network, including internal manufacturing facilities, external contract manufacturers, laboratories, suppliers, distributors, and other third‑party partners. The role partners closely with cross‑functional stakeholders to ensure compliance risks and systemic issues identified through audits are appropriately documented, escalated, trended, and resolved, while driving consistency, continuous improvement, and sustained quality oversight across Spy Glass Pharma’s global supply chain.

This role will also lead to inspection readiness activities such as pre‑approval inspection (PAI) and regulatory surveillance audits.

• Serve as the primary Quality lead for regulatory authority inspections (e.g., FDA) partnering closely with QA to address inspection product related requests, questions and issues.
• Lead inspection readiness simulations internally and at partner facilities to secure seamless product approvals.
• Manage consultants supporting PAI readiness assessments, preparations, and mock inspection activities
• Facilitate remediations/risk mitigations with internal and external functional teams to ensure successful PAI outcome
• Provide leadership, coaching and training to audit team and SMEs on (PAI) inspection preparation and readiness
• Maintain QMS compliance with both drug regulations (21 CFR Part 210/211) and medical device requirements (21 CFR Part 820 / ISO 13485), specifically addressing 21 CFR Part 4 for combination products.

• Lead and oversee execution of quality system activities to ensure compliance with internal procedures, applicable regulatory requirements and standards for Spy Glass’ product life cycle including supplier’s lifecycle management program
• Manage and lead the quality compliance group to ensure effective implementation and compliance monitoring and maintenance of Spy Glass Quality System
• Provide strategic and operational leadership for core Quality System activities and processes including continuous…