Remote Director, Global Quality Systems & GxP Compliance

Outlook Therapeutics Inc.; Arkansas; Hybrid; USD 180,000 - 220,000; Full time

Benefits offered by this job

Competitive base salary and equity

Medical, dental, and vision insurance

401(k) with company match

Generous paid time off and holidays

Direct access to leadership and growth

Job summary

Outlook Therapeutics Inc. is seeking a Director of Quality Systems and GxP Compliance to lead the quality systems backbone for a company expanding toward global commercial maturity.

You will drive GxP compliance, QA strategy, and collaboration with Regulatory, Technical Operations, and Commercial teams, putting patient access at the forefront. The role offers remote work for a US-based candidate, with responsibility spanning the US, EU, UK, MENA, LATAM, and APAC regions, and includes oversight

Qualifications

• Bachelor’s degree in a life-science or related field.
• 10+ years of experience in biopharmaceutical or pharmaceutical Quality.
• Strong knowledge of domestic and international GMP regulations.
• Proven experience building and maintaining Quality Systems.
• Experience partnering with multi-disciplinary teams across Regulatory, Technical Operations, and Commercial.

Responsibilities

• Lead Quality Systems and GxP Compliance operations, including Document Control, Change Control, Deviations, CAPA, and Product Complaint support.
• Build and maintain quality programs and the internal Quality Management System.
• Lead the Change Control Review Board and Quality Council.
• Drive continuous improvement across vendor and internal quality systems, incorporating outcomes from Quality Management Review activities.
• Oversee inspection readiness activities, including mock audits and SME preparation.

Skills

Quality leadership

GxP compliance

Regulatory knowledge

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in life sciences

Tools

Veeva

TrackWise

MasterControl

Job description

Outlook Therapeutics Inc. is seeking a Director of Quality Systems and GxP Compliance to lead the quality systems backbone for a company expanding toward global commercial maturity.

You will drive GxP compliance, QA strategy, and collaboration with Regulatory, Technical Operations, and Commercial teams, putting patient access at the forefront. The role offers remote work for a US-based candidate, with responsibility spanning the US, EU, UK, MENA, LATAM, and APAC regions, and includes oversight