Senior Manager, Quality Assurance

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:

The Senior Manager of Quality Assurance role involves support for the Research & Development (R&D) and Operations teams ensuring that all processes meet regulatory requirements and company Quality Management System. This position reports to the Senior Director Quality with direct oversight of one other QA team member currently. This position will also play a key role that supports clinical and manufacturing operations. The Senior Manager ensures compliance with cGMP GCP and GLP requirements through direct oversight of QA process including document control supplier qualification deviations/CAPA and batch disposition and serves as a trusted cross-functional partner as the company advances from clinical development toward commercialization.

Essential Duties & Responsibilities:

• Provide direct leadership coaching and performance management for the Quality Assurance Engineer; setting team priorities workload and individual development plans; delegate and review work to build team capability and bench strength.
• 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.
• Responsible for managing GxP quality requirements supporting product development phase appropriate and lifecycle management of clinical products and the commercialization and launch.
• Provide Quality oversight to ensure clinical and commercial product is manufactured tested stored and distributed according to cGMPs and other applicable regulations.
• Ensure QA review and approval of records and personally perform and provide key QA duties/support to CMC/Device development and operations teams during product development clinical and commercial manufacturing including:
  • Review and approve Master Production Records from Contract Manufacturing Organizations to include Drug Substance manufacturing Drug Product manufacturing Finished Drug Product labeling and packaging operations and external laboratory oversight.
  • Reviews and approves executed records certificates of analysis client notifications specifications qualifications investigations deviations CAPA certificate of conformance
  • Perform product release for clinical investigational and commercial distribution
  • Raw Material Qualification
  • Review and approve validation protocols and validation reports as required.
  • Provide Quality assessments and approvals for internal and external Change Controls impacting clinical or commercial products

• Serve as designated representative with critical CMOs and work with technical operations to address manufacturing issues at the CMO.

• Own the QA SOPs and work instruction lifecycle authoring and delegating new documents and revisions to support quality functional activities.
• Support Management review process through preparation of data and meeting minutes
• Lead QA initiatives/projects for quality and continuous improvements
• Understand and interpret regulatory policies and guidance as it pertains to GMP requirements and ensures compliance
• Support regulatory agency inspection readiness activities including mock inspections gap assessments and agency response coordination.
• Collaborate with Regulatory Affairs Clinical Operations Medical Affairs Manufacturing and R&D
• Other duties as assigned.

Qualifications Required for Position:

• B.S. in Chemistry Biology Engineering or related science.
• 10 years of relevant experience in pharmaceutical industry with at least 5 years with direct quality assurance experience (additional medical device experience a plus)
• 3 years of people management or team leadership experience (direct reports preferred) with demonstrated ability to coach develop and manage QA professionals
• In-depth understanding of QA methodologies and process to support early phase development into late stage and commercial manufacturing.
• Experience in clinical phases of development (ie. Phase 2 through Phase 3)
• Knowledge of applicable FDA regulations (cGMP/GLP/GCP/QMSR/ISO) and ICH guidelines

• Experience with combination products (drug/device) and 21 CFR Part 4 preferred.
• Experience hosting or supporting regulatory inspections (FDA or other health authorities).

• Excellent analytical and problem-solving skills to identify and resolve issues efficiently.
• Experience in engaging vendors and CMOs
• Experience in performing raw material and supplier qualification audits
• Ability to influence cross-functional stakeholders and make sound risk-based quality decisions.
• Strong attention to detail with the judgment to prioritize and delegate effectively.
• Strong verbal skills technical writing skills and ability to work with others in a collaborative manner.
• Mentoring and training QA team members to enhance their skills and performance.

Certificates/Licenses Required for Role:

• ASQ Certification (CQE CQA) a strong plus

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:

Senior Manager