Pharmaceutical/Biologics R&D Quality Lead

Glaukos – Pharmaceutical/Biologics R&D Quality Lead

Location: Aliso Viejo, CA

How Will You Make an Impact?

The R&D Quality Lead, Pharma/Biologics will play a key role in advancing quality strategy and supporting the successful development of pharmaceutical, biologic, and combination products. This position serves as a trusted quality partner across research, development, regulatory, clinical, and manufacturing functions, helping ensure compliance, product quality, and operational excellence throughout the product lifecycle. The role also serves as the primary Quality liaison for external development and manufacturing partners.

What Will You Do?

• Serve as the GMP and R&D Quality subject matter expert for pharmaceutical, biologic, and combination product development programs.
• Provide quality oversight for outsourced development and manufacturing activities, including drug substance, drug product, biologic intermediates, clinical trial materials, analytical development, validation, manufacturing, packaging, labeling, release, and stability programs.
• Partner with cross-functional teams to provide quality input into product development plans, technology transfer activities, validation readiness, supplier oversight, and commercialization efforts.
• Review and approve development and validation protocols, reports, specifications, analytical methods, batch documentation, release records, and CMC documentation.
• Support and maintain phase-appropriate GMP quality systems, including change control, deviations, CAPA, supplier quality management, training, documentation control, and data integrity programs.
• Ensure quality documentation complies with company standards, industry regulations, and global regulatory expectations.
• Provide quality review and support for regulatory submissions, including investigational applications, marketing applications, annual reports, and regulatory updates.
• Participate in audits, inspections, and cross-functional project teams to drive continuous improvement and compliance excellence.
• Communicate project progress, risks, and recommendations to leadership and key stakeholders.

How Will You Get Here?

Education

• Bachelor's degree in a scientific discipline such as Biology, Chemistry, Pharmacy, Engineering, Mathematics, or a related field required.
• Master's degree preferred.

Experience

• 12+ years of pharmaceutical, biologic, or combination product industry experience, or 8+ years with a Master's degree.
• Strong experience in R&D Quality, CMC, GMP compliance, clinical supply, supplier oversight, and regulatory submission support.
• Demonstrated experience supporting pharmaceutical and biologic product development programs.
• Experience applying GMP and regulatory requirements in development or manufacturing environments.
• Knowledge of FDA, EMA, ICH, and global GMP regulations.
• Understanding of validation principles for pharmaceutical manufacturing, testing, and equipment systems.
• Familiarity with global CMC development and regulatory filing processes.
• Strong project management, communication, and stakeholder management skills.
• Audit experience and supplier quality oversight experience preferred.
• Ability to effectively manage multiple priorities and navigate complex quality and compliance challenges in a fast-paced environment.

Why Join Glaukos?

At Glaukos, you'll have the opportunity to contribute to innovative therapies that improve patient outcomes while partnering with talented teams across research, development, clinical, regulatory, and manufacturing functions. This role offers the chance to make a meaningful impact on the development of next-generation pharmaceutical and biologic products in a collaborative, mission-driven environment.

#GKOSUS

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.