Manager, Quality Assurance

About SpyGlass Pharma:At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care.Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology, IOL development, and commercial success. Led by a proven team with expertise in science, R&D, communications, and operations, SpyGlass Pharma takes ideas from inception through commercialization.Our commitment to actively improving patients’ quality of life drives the company to innovate and succeed.Learn more at www.spyglasspharma.comSummary:The Quality Assurance Manager is pivotal to ensuring the successful execution of the Quality Management System at SpyGlass Pharma. This role involves support for the Research & Development R&D and Operations teams, ensuring that all processes meet regulatory requirements and company standards. This position will also play a key role in raw material qualification, product release, and continuous improvement initiatives to maintain and enhance quality standards.Essential Duties & Responsibilities:Support execution of Quality Management System to meet regulatory requirements.Support R&D and Operations team in areas of Design Control, Product Change Management and Risk Management.Raw Material Qualification and Product Release Support.Change control and Quality Events review and approval.Back up quality rep for suppliers, CMO, etc.Support Management review process through preparation of data and meeting minutes.Lead continuous improvement projects of Quality Management.Other duties as assigned.Qualifications Required For Position:3+ years of experience with direct quality assurance experience in pharmaceutical and medical device industry.B.S. in Chemistry, Biology, Engineering or related science.Strong familiarity with relevant regulatory standards, including 21 CFR Part 820, 210, and 211.Experience in Quality Management System execution.Strong attention to detail and collaboration.Certificates/Licenses Required For Role:ASQ Certification (Cqe, Cqa) preferredSpyGlass 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.

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