Sr. Manager, Quality

About SpyGlass Pharma:

At SpyGlass Pharma we are focused on improving and preserving the vision of patients suffering from chronic eye conditions while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra We create for patients doesnt just live on our walls but drives our decision making as we build the company creating the products processes and culture that make it happen.

This team has delivered a solid foundation of development and clinical data enabling over $200 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.

Summary:

The Sr. Manager of Quality is responsible for supporting SpyGlass Pharmas Pre-Approval Inspection (PAI) Readiness Program. This role works closely with Director of Quality Assurance and is key in ensuring that SpyGlass and contract manufacturing organizations are robust and align with regulatory expectations for commercial manufacturing.

Essential Duties & Responsibilities:

• Maintain expert knowledge of FDA USP cGMP and other quality system standards and regulations applying these to SpyGlass Pharmas 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.

Qualifications Required For Position:

• Bachelors 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 Pharmas culture and values
• Willingness to travel 10-15% (both domestic and international)
  

Certificates/Licenses Required For Position:

• Qualified Auditor Certification preferred

Why SpyGlass Pharma

• We are offering a range of $160000 - $180000 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:

Manager