Principal Quality Engineer - Pharma Development

Principal Quality Engineer - Pharma Development (Aliso Viejo, CA or Burlington, MA)

How Will You Make An Impact?

Glaukos is seeking a Principal Quality Engineer - Pharma Development with expertise in drug/device combination products. This role will lead implementation of quality strategy and oversee GMP compliance to ensure effective operations across R&D, Applied Research, Regulatory Affairs, and CMOs. The Principal Quality Engineer will serve as the Quality liaison for all QA matters, supporting both clinical and commercial development.

This is an opportunity to shape quality systems in a growing organization developing innovative combination products. You will collaborate with top-tier teams and CMOs, influencing quality at every stage of development.

What Will You Do?

• Act as GMP Quality Subject Matter Expert for assigned drug programs.
• Oversee quality aspects of pharmaceutical development in outsourced environments for drug substance, drug product, and clinical trial materials.
• Review and approve validation protocols/reports, specifications, batch records, and product releases.
• Ensure compliance with quality systems (change control, deviations, complaints, training, etc.).
• Provide QC review of documents supporting regulatory submissions (CMC, IND, NDA, etc.).
• Conduct or participate in audits of internal teams and external partners.
• Represent Quality on cross-functional project teams and support process improvements.
• Support special projects and departmental objectives as needed.
• Provide backup support to QA colleagues when required.

How Will You Get Here?

• Education & Experience:
  
  
  
  • 12+ years of industry experience, or 8+ years with a Master's degree.
  • Strong background in pharmaceutical development and combination products.
  
  
• Technical Expertise:
  
  
  
  • In-depth knowledge of GMP, FDA/EMA/ICH guidelines, and validation practices.
  • Familiarity with CMC regulatory filings (USA, EU, global).
  • Working knowledge of technical/analytical aspects of pharmaceutical manufacturing.
  
  
• Skills & Abilities:
  
  
  
  • Proven project management and cross-functional leadership.
  • Strong oral and written communication skills.
  • Ability to exercise sound judgment and handle complex situations independently.
  • Audit management experience preferred.