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Director, Quality Assurance
4 months ago
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.com
Summary:
The Quality Assurance Director is responsible for overseeing the Quality function and strategy in collaboration with the Senior Director of Quality. The Quality Assurance Director represents Quality on cross-functional teams, oversees contract manufacturing, supports R&D development, and leads audits and inspections. This role involves promoting a Culture of Quality within the organization, leading continuous improvement initiatives, and ensuring adherence to quality management systems and regulatory requirements. Additionally, this position plays a crucial role in maintaining product quality and ensuring compliance with cGMP and regulatory standards throughout the product lifecycle, from development to commercial use.
Essential Duties & Responsibilities:
- In partnership with the Senior Director of Quality, establish overall short and long-term quality strategy and objectives.
- Develop and implement quality procedures in compliance with regulatory requirements and industry standards.
- Ensure quality management system is maintained and executed throughout the organization.
- Promote the Culture of Quality throughout the organization and lead continuous improvement initiatives.
- Represent Quality on cross-functional operational teams (i.e. CMC) and serve as a resource for quality and compliance questions, issues, and planning across the development organization.
- Coordinate with external vendors, contractors, and consultants to ensure validation, tech transfer, and production schedules are met.
- Support R&D development through late-stage pharmaceutical development.
- Oversee contract manufacturing organizations and represent QA as the person-in-the-plant (PIP) during manufacturing campaigns.
- Collaborate with internal and external stakeholders on deviation investigations, CAPA plans, change controls, and revisions to documentation.
- Support internal audits, supplier audits, and regulatory inspections.
- Perform review of batch records, test data, perform product dispositions, and issue CoAs.
- Lead, mentor, and support junior members of the Quality team.
- Quality oversight of the transfer, validation, manufacture, release, and disposition of clinical supplies.
- Develop quality management systems program for the oversight of the manufacture, packaging, testing, labeling, and distribution of clinical trial material.
- Maintain and improve Quality Systems to ensure that the systems employed are flexible and phase-appropriate.
- Mentor quality personnel to execute the program and transition from early stage to Phase 3/Registration of commercial-ready products.
- Development team quality lead responsible for ensuring project planning, guidance, and decision-making is aligned with current regulations and industry best practices.
- Prepare team for successful PAIs through developmental plans including auditing contracted partners and suppliers, CMC data and documentation review, identification of areas requiring supplementation, assessment of quality systems, and preparation of SMEs for presentation and discussion with inspectors.
- Other duties as assigned.
Minimum Qualifications:
- 10+ years of experience in quality and/or compliance in the pharmaceutical industry.
- S. in Chemistry, Biology, Engineering, or related science.
- Understand quality and compliance requirements for pharmaceutical quality systems, late stage development, manufacturing, testing (including stability), and validation.
- Understanding of clinical and preclinical compliance to support development work at contracted partners.
- Knowledge of 21 CFR 210/211, ICH Q1A Stability Testing of New Drug Substances and Products, ICH Q2 Validation of Analytical Procedures, ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System
- Strong attention to detail and collaboration.
- Excellent written and verbal communication.
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.
