Global Quality Assurance Director – Regulatory & GxP Leader

Aerogen Pharma Limited; Morrisville (NC); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive bonus plan

Above-market life insurance

Opportunities for development and professional growth

Employee-led program for team unity

Charity donations from profits

Job summary

Aerogen Pharma Limited is seeking a Senior Director of Quality Assurance in Morrisville, NC. This key leadership role entails developing and maintaining quality strategies ensuring compliance with FDA standards. Responsibilities include overseeing quality assurance systems, managing a small QA team, and providing input for audits and inspections. The ideal candidate has over 10 years of experience in the biopharmaceutical industry, preferably in quality assurance. Attractive benefits and career growth opportunities are offered within a diverse and inclusive culture.

Qualifications

• 10+ years experience in the biopharmaceutical industry.
• 10+ years working in quality assurance with understanding of cGMP.
• Direct experience with health authority inspections.

Responsibilities

• Develop and implement QA policies compliant with global standards.
• Maintain SOPs/Quality Systems with changing business requirements.
• Provide leadership for the qualifications of GxP service providers.
• Oversee quality investigations for drug and device products.
• Implement risk assessments to identify quality issues.
• Establish internal audits to ensure compliance.
• Coordinate external audits and maintain quality agreements.

Skills

Experience with electronic documentation systems

Laboratory QC experience

Education

Bachelor’s degree in a scientific discipline

Job description

Aerogen Pharma Limited is seeking a Senior Director of Quality Assurance in Morrisville, NC. This key leadership role entails developing and maintaining quality strategies ensuring compliance with FDA standards. Responsibilities include overseeing quality assurance systems, managing a small QA team, and providing input for audits and inspections. The ideal candidate has over 10 years of experience in the biopharmaceutical industry, preferably in quality assurance. Attractive benefits and career growth opportunities are offered within a diverse and inclusive culture.