Director, Quality Assurance

You're a seasoned leader in Quality Assurance, boasting a pharmaceutical industry background, and who is:

• Excited about joining a talented team with significant progress toward bringing an revolutionary, life-changing product to market
• Ready to lead quality initiatives in a dynamic, innovative pharmaceutical environment
• Motivated by a pivotal role supporting the flagship product with all the associated responsibility and opportunity
• Eager to join a passionate group with a collaborative, energetic culture to make a significant impact

If this sounds like you, welcome to SpyGlass Pharma!

At SpyGlass Pharma, we're pioneering advancements in ophthalmic therapeutics to address unmet needs in cataract/lens replacement surgery and chronic ophthalmic diseases.

We're seeking a Director of Quality Assurance to join our team and drive excellence in product quality and regulatory compliance.

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).

About SpyGlass Pharma:

SpyGlass Pharma is a privately held, VC-funded start-up developing ophthalmic therapeutics for cataract/lens replacement, glaucoma treatment and other chronic ophthalmic diseases.

Founded by veteran, successful entrepreneurs, our team includes engineers, scientists, and clinicians with deep roots in pharmaceuticals, drug delivery and medical devices. Our founders’ experience developing new devices, from inception to clinical application, spans 30+ years, 100 patents, and multiple products in clinical use worldwide.

Our commitment to actively improving patients’ quality of life drives the company to innovate and succeed.

Learn more at www.spyglasspharma.com

Job Type: Full-time

Pay: $175,000.00 - $225,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Pharmaceutical Quality: 10 years (Required)
• 21 CFR 210/211 and ICH Quality Guidelines: 5 years (Required)

Ability to Commute:

• Aliso Viejo, CA 92656 (Required)

Ability to Relocate:

• Aliso Viejo, CA 92656: Relocate before starting work (Required)

Work Location: Hybrid remote in Aliso Viejo, CA 92656