Director, Quality Compliance

About SpyGlass Pharma:

At SpyGlass 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 SpyGlass Pharma is entering an exciting stage of growth as we advance our lead program the SpyGlass BIM-IOL through Phase 3 clinical development.

Summary:

We are seeking a Director of Quality Compliance to join our team at SpyGlass 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 highquality audit execution across SpyGlass Pharmas global manufacturing and supply network including internal manufacturing facilities external contract manufacturers laboratories suppliers distributors and other thirdparty partners. The role partners closely with crossfunctional 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 SpyGlass Pharmas global supply chain. This role will also lead to inspection readiness activities such as pre-approval inspection (PAI) and regulatory surveillance audits.

Essential Duties & Responsibilities:

• 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 SpyGlass product life cycle including suppliers lifecycle management program
• Manage and lead the quality compliance group to ensure effective implementation and compliance monitoring and maintenance of SpyGlass Quality System
• Provide strategic and operational leadership for core Quality System activities and processes including continuous improvement initiatives trending and monitoring of quality system performance/risks/mitigations management reviews and product annual reviews
• Oversee Management Reviews
• Ensure all GxP computerized systems are validated in compliance with quality policies standards and procedures and are maintained in validated state throughout the lifecycle
• Collaborate with crossfunctional stakeholders to identify compliance gaps emerging risks and opportunities for proactive compliance or continuous improvement initiatives.

• Collaborate with QA RA Medical Affairs Manufacturing and R&D to ensure product quality complaints are assessed for potential safety regulatory reporting recall field action and manufacturing investigations

• Design and execute the annual global internal and external audit programs.
• Lead risk-based audits of internal manufacturing sites and external partners including contract manufacturers laboratories suppliers distributors and other third parties.
• Oversee lifecycle compliance and performance monitoring of Contract Manufacturing Organizations (CMOs) and critical hardware/component vendors.
• Promote awareness of current regulatory expectations across clinical and commercial manufacturing platforms and incorporate identified trends into audit program strategy and focus
• Draft negotiate and enforce Quality Agreements with external partners
• Identify assess and appropriately escalate compliance risks and systemic issues to management to support timely evaluation and resolution

Qualifications Required For Position:

• Bachelors degree in Life Sciences Chemistry Pharmacy or Biomedical Engineering. Advanced degree preferred
• 12 years in a regulated GxP pharmaceutical or biotechnology setting (at least 3 years focused on drug-device combination products is a plus)
• Strong knowledge of U.S regulatory requirements (GMP/GXPs) & direct operational knowledge of 21 CFR Part 4 210/211 820 ISO 13485 and ISO 14971
• Excellent knowledge of Quality Management Systems Quality Compliance programs Business processes and industry best practices for clinical and commercial pharmaceutical products
• Proven track record hosting health authority audits and leading global supplier audit teams (Sterile ophthalmic and combination products experience preferred). Certified Quality Auditor (ASQ CQA/CQE) is a strong plus
• Demonstrated leadership experience in managing quality teams and oversight of pharmaceutical quality system management
• Demonstrate direct experience leading FDA inspections (ie. PAI) for pharmaceutical products
• Excellent negotiation skills and the ability to communicate effectively with all levels of the organization and external stakeholders
• Excellent knowledge of Quality Management Systems/Quality Compliance programs/processes and industry best practices for development and commercial pharmaceutical products
• Technical expertise in Microsoft Office (Outlook Word Excel PowerPoint)
• Willingness to travel 10-15% (both domestic and international)

Certificates/Licenses Required For Role:

• Qualified Auditor Certification a strong plus

Why SpyGlass Pharma

• We are offering a range of $200000 - $225000 based on experience and qualifications along with an Annual Bonus opportunity.
• Share in our success with stock options giving you a stake in the companys 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.

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity marital or veteran status disability or any other legally protected status.

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.

Required Experience:

Director