Internal Quality Operations Manager

📋 Description

• Support transition to electronic QMS for drug dev lifecycle
• Ensure compliance with GLP, GCP, GMP and FDA/global standards
• Involves inspection readiness, regulatory submissions, vendor oversight
• Collaborate across Clinical, Regulatory, IT, CMC and Commercial teams
• Lead documentation, training, deviations, CAPA, change control
• Promote a quality culture and cross-functional leadership

🎯 Requirements

• Bachelor’s in a scientific discipline
• Experience transitioning to eQMS from paper systems
• Familiar with IND/NDA/BLA submissions and inspections
• GxP environments and multi-stage drug development
• Experience with CSV/validation is a plus
• Willingness to travel to vendor/regulatory meetings

🎁 Benefits

• Competitive compensation and total rewards
• Generous time off and conference opportunities
• Work in a collaborative, team-oriented environment
• Impactful work in rare diseases