Company Description

Orphai Therapeutics is dedicated to discovering and developing transformative therapies for patients with serious, underserved diseases. Our lead programs are advancing toward the clinic in pulmonary hypertension and bronchiolitis obliterans syndrome in post-lung transplant patients. We combine scientific rigor with a technology-enabled approach to accelerate development and improve patient outcomes.

Joining Orphai Therapeutics is an opportunity to help build and scale a drug development organization from the ground up—pairing strong execution with the urgency and mission focus of a company working to change patients’ lives.

Role Description

The Pharmaceutical GxP Quality Assurance Manager/Auditor ensures that all activities comply with GxP requirements. This role oversees the Quality Management System (QMS), conducts internal and external audits, supports regulatory inspections, and drives continuous improvement to maintain a robust and quality compliant state of control across pharmaceutical operations.

Key Responsibilities

• Develop and implement the pharmaceutical QMS to ensure quality compliance with regulatory requirements.
• Plan and conduct internal and external GxP audits. Qualify vendors.
• Ensure investigations meet pharmaceutical expectations for root‑cause analysis, data integrity, and CAPA effectiveness.
• Evaluate change controls affecting processes, equipment, analytical methods, packaging, and distribution.
• Oversee review and approval of batch manufacturing, packaging, and testing documentation.

Required Qualifications

• Bachelor’s degree in sciences or related field.
• 10 years of pharmaceutical QA experience.
• Working knowledge of GMP, GLP, and GCP regulations, including FDA 21 CFR Parts 11, 58, 210/211, 312, 820, and ICH guidelines.
• Demonstrated experience conducting pharmaceutical GxP audits.
• Highly detail oriented with strong organizational skills.
• Ability to travel for external audits.
• Proficient in Microsoft Office Suite including Word, Excel and PowerPoint.

Additional Information

We offer great perks:

Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great value on our teams’ well-being

·      Competitive salaried compensation - we value our employees and show it

·      Equity - we want every employee to be a stakeholder

·      401k plan - we facilitate your retirement goals

·      Remote work – because family life is important

·      The opportunity to develop a revolutionary healthcare products and save millions of lives!

·      For this role, we provide visa assistance for qualified candidates.

Orphai Therapeutics does not accept agency resumes.

Orphai Therapeutics is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.