SpyGlass Pharma, Inc
Sr. Manager, Quality Compliance
SpyGlass Pharma, Inc, Aliso Viejo, California, United States, 92656
Join to apply for the
Sr. Manager, Quality Compliance
role at
SpyGlass Pharma, Inc.
Learn more about the general tasks related to this opportunity below, as well as required skills. Join to apply for the
Sr. Manager, Quality Compliance
role at
SpyGlass Pharma, Inc. Get AI-powered advice on this job and more exclusive features. 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 $120 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: We are seeking a Senior Manager of Quality Compliance to join our team at SpyGlass Pharma. This role is responsible for leading the company’s GxP compliance activities and overseeing the development and maintenance of robust quality systems. The Senior Manager will manage core elements of the Quality Management System (QMS), including document control, training, vendor oversight, and quality performance monitoring. This role is essential in driving inspection readiness, system scalability, and continuous improvement to meet global regulatory expectations. Maintain expert knowledge of FDA, USP, cGMP, and other quality system standards and regulations, applying these to SpyGlass Pharma’s operations. Oversee QMS administration and monitor system performance. Oversee the Vendor Management Program and support internal and external GXP audits, ensuring efficient retrieval and presentation of documents and records. Lead the project for transitioning to a new validated electronic Quality Management System (eQMS). Lead the Quality Management Review process, identifying and addressing gaps within the quality management system. Contribute to the development of quality system performance metrics and monitor their effectiveness. Oversee the Document Control process, ensuring compliance with procedures and regulatory requirements throughout the document lifecycle. Assist in the development and revision of SOPs and controlled documents to support GXP-regulated activities.This includes building a robust QMS supporting commercial manufacturing. Ensure the QMS documentation effectively supports system functionality and product quality. Manage GXP training, collaborating with subject matter experts to develop and deliver training materials. Provide hands-on support for users with procedural writing, workflow management, and record uploads. Contribute to cross-functional teams focused on continuous improvement of quality system processes. Qualifications Required For Position: Bachelor’s degree in a scientific discipline or equivalent experience Minimum of 5 years of progressive experience in the biotechnology or pharmaceutical industry Expert knowledge of pharmaceutical quality and learning management systems 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) Certificates/Licenses Required For Position: Qualified Auditor Certification preferred Why SpyGlass Pharma? We are offering a range of $160,000 - $180,000, based on experience and qualifications, along with an Annual Bonus opportunity. 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. 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 JOBS@SPYGLASSPHARMA.COM and let us know the nature of your request and your contact information. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at SpyGlass Pharma, Inc. by 2x Get notified about new Quality Compliance Manager jobs in
Aliso Viejo, CA . Quality Assurance (QA) Manager - SaaS Learning Platform Irvine, CA $90,000.00-$120,000.00 1 week ago Senior Manager, Food Safety & Quality Assurance Newport Beach, CA $147,000.00-$217,500.00 1 week ago Orange County, CA $100,000.00-$130,000.00 3 days ago San Clemente, CA $100,000.00-$120,000.00 1 week ago Orange, CA $80,000.00-$100,000.00 4 days ago Irvine, CA $150,000.00-$180,000.00 2 days ago Assurance Manager, Quality Management - IS Assurance Irvine, CA $195,000.00-$260,000.00 10 months ago Santa Ana, CA $120,000.00-$175,000.00 2 weeks ago Manufacturing Operations Manager (food/beverage manufacturer) Corona, CA $145,000.00-$155,000.00 1 week ago Manufacturing Manager - Bioprosthetic Devices Irvine, CA $150,000.00-$170,000.00 2 weeks ago Clinical Laboratory Manager 1- Corelab Irvine- FT Day ShiftClinical Laboratory Manager 1- Corelab Irvine- FT Day Shift Orange, CA $120,000.00-$140,000.00 4 weeks ago Huntington Beach, CA $20.00-$24.00 1 week ago Client Director - Water Business - Southern California Orange County, CA $123,000.00-$160,000.00 2 weeks ago Architectural Manager – Quality Assurance & PermittingCall Center Quality Assurance SpecialistCall Center Quality Assurance Specialist Camp Pendleton, CA $75,000.00-$80,000.00 1 month ago Call Center Quality Assurance Specialist We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Sr. Manager, Quality Compliance
role at
SpyGlass Pharma, Inc.
Learn more about the general tasks related to this opportunity below, as well as required skills. Join to apply for the
Sr. Manager, Quality Compliance
role at
SpyGlass Pharma, Inc. Get AI-powered advice on this job and more exclusive features. 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 $120 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: We are seeking a Senior Manager of Quality Compliance to join our team at SpyGlass Pharma. This role is responsible for leading the company’s GxP compliance activities and overseeing the development and maintenance of robust quality systems. The Senior Manager will manage core elements of the Quality Management System (QMS), including document control, training, vendor oversight, and quality performance monitoring. This role is essential in driving inspection readiness, system scalability, and continuous improvement to meet global regulatory expectations. Maintain expert knowledge of FDA, USP, cGMP, and other quality system standards and regulations, applying these to SpyGlass Pharma’s operations. Oversee QMS administration and monitor system performance. Oversee the Vendor Management Program and support internal and external GXP audits, ensuring efficient retrieval and presentation of documents and records. Lead the project for transitioning to a new validated electronic Quality Management System (eQMS). Lead the Quality Management Review process, identifying and addressing gaps within the quality management system. Contribute to the development of quality system performance metrics and monitor their effectiveness. Oversee the Document Control process, ensuring compliance with procedures and regulatory requirements throughout the document lifecycle. Assist in the development and revision of SOPs and controlled documents to support GXP-regulated activities.This includes building a robust QMS supporting commercial manufacturing. Ensure the QMS documentation effectively supports system functionality and product quality. Manage GXP training, collaborating with subject matter experts to develop and deliver training materials. Provide hands-on support for users with procedural writing, workflow management, and record uploads. Contribute to cross-functional teams focused on continuous improvement of quality system processes. Qualifications Required For Position: Bachelor’s degree in a scientific discipline or equivalent experience Minimum of 5 years of progressive experience in the biotechnology or pharmaceutical industry Expert knowledge of pharmaceutical quality and learning management systems 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) Certificates/Licenses Required For Position: Qualified Auditor Certification preferred Why SpyGlass Pharma? We are offering a range of $160,000 - $180,000, based on experience and qualifications, along with an Annual Bonus opportunity. 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. 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 JOBS@SPYGLASSPHARMA.COM and let us know the nature of your request and your contact information. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at SpyGlass Pharma, Inc. by 2x Get notified about new Quality Compliance Manager jobs in
Aliso Viejo, CA . Quality Assurance (QA) Manager - SaaS Learning Platform Irvine, CA $90,000.00-$120,000.00 1 week ago Senior Manager, Food Safety & Quality Assurance Newport Beach, CA $147,000.00-$217,500.00 1 week ago Orange County, CA $100,000.00-$130,000.00 3 days ago San Clemente, CA $100,000.00-$120,000.00 1 week ago Orange, CA $80,000.00-$100,000.00 4 days ago Irvine, CA $150,000.00-$180,000.00 2 days ago Assurance Manager, Quality Management - IS Assurance Irvine, CA $195,000.00-$260,000.00 10 months ago Santa Ana, CA $120,000.00-$175,000.00 2 weeks ago Manufacturing Operations Manager (food/beverage manufacturer) Corona, CA $145,000.00-$155,000.00 1 week ago Manufacturing Manager - Bioprosthetic Devices Irvine, CA $150,000.00-$170,000.00 2 weeks ago Clinical Laboratory Manager 1- Corelab Irvine- FT Day ShiftClinical Laboratory Manager 1- Corelab Irvine- FT Day Shift Orange, CA $120,000.00-$140,000.00 4 weeks ago Huntington Beach, CA $20.00-$24.00 1 week ago Client Director - Water Business - Southern California Orange County, CA $123,000.00-$160,000.00 2 weeks ago Architectural Manager – Quality Assurance & PermittingCall Center Quality Assurance SpecialistCall Center Quality Assurance Specialist Camp Pendleton, CA $75,000.00-$80,000.00 1 month ago Call Center Quality Assurance Specialist We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr