Director, Quality Assurance

2 weeks ago

Aliso Viejo, United States Spyglass Pharma Full time
Job DescriptionJob DescriptionSalary: $175k/yr - $225k/yr

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 


Key Elements + Responsibilities:


As the Director of Quality Assurance, you will be instrumental in shaping our quality strategy and ensuring adherence to regulatory standards. You will be responsible for developing and implementing quality policies and procedures, building and maintaining a robust quality management system, supporting R&D development of product, and ensuring product quality of clinical manufacturing. You’ll be playing a crucial role in maintaining product quality, ensuring regulatory compliance, and driving continuous improvement initiatives.


Other Responsibilities Include:


  • Collaborating with the Head of Quality to establish and implement short and long-term quality objectives.
  • Championing a Culture of Quality throughout the organization and leading continuous improvement efforts.
  • Developing and implementing robust quality policies and procedures in alignment with regulatory requirements.
  • Serving as the quality expert on cross-functional teams, providing guidance on quality and compliance matters.
  • Supporting R&D development activities by providing validation and tech transfer guidance.
  • Overseeing contract manufacturing organizations and representing QA during manufacturing campaigns.
  • Conducting internal audits, supplier audits, and regulatory inspections as required.
  • Reviewing batch records, test data, and issuing Certificates of Analysis.
  • Collaborating with stakeholders on deviation investigations, CAPA plans, and change controls.
  • Mentoring and supporting junior members of the Quality team.


Minimum Qualifications:


  • Bachelor's degree in Chemistry, Biology, Engineering, or related field.
  • 10+ years of experience in quality and/or compliance within the pharmaceutical industry.
  • In-depth knowledge of pharmaceutical quality systems, development, manufacturing, testing (including stability), and validation.
  • Familiarity with relevant regulations and guidelines, including 21 CFR 210/211 and ICH Quality Guidelines.
  • Strong communication skills, both written and verbal, with the ability to effectively present information to diverse audiences.
  • Attention to detail, accuracy, and commitment to producing high-quality work.
  • Demonstrated ability to write clear and concise documents.


Preferred Qualifications:


  • Advanced degree in Chemistry, Biology, Engineering, or related field.
  • Experience with stability testing, pharmaceutical development, and quality risk management.
  • Certification in quality management (e.g., ASQ, Six Sigma).


 

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.

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