Director, Quality (PAI Readiness Focus)

Spyglass Pharma•Aliso Viejo, CA

10d•$180,000 - $200,000

About The Position

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” doesn’t 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.

Requirements

Bachelor’s degree in scientific discipline or equivalent experience.
Minimum of 10 years of progressive experience in the biotechnology or pharmaceutical industry.
Recent 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)

Nice To Haves

Qualified Auditor Certification preferred

Responsibilities

Maintain expert knowledge of FDA, USP, cGMP, and other quality system standards and regulations, applying these to SpyGlass Pharma’s operations.
Support PAI readiness activities and ensure the site and CMO’s and Contract Labs are ready for PAI inspections
Accountable for execution of QMS Gap Assessment Activities.
Lead and coordinate successful gap remediation activities at both SpyGlass and contract manufacturers.
Point of contact for functional team remediation activities.
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.