Quality Operation Manager (GMP)

📋 Description

• Support transition to an electronic quality management system (eQMS).
• Ensure Quality System supports all drug development stages.
• Maintain GxP compliance and FDA/global regulatory expectations.
• Assist inspection readiness, regulatory submissions, and vendor oversight.
• Foster a culture of quality and regulatory compliance across the org.
• Collaborate with Clinical, Regulatory, IT and Commercial teams.

🎯 Requirements

• Bachelor’s degree in a scientific discipline.
• Experience transitioning to an eQMS.
• IND/NDA/BLA submissions; inspections; GxP.
• Several years of quality experience in pharma/biotech.
• eQMS validation experience; CSV/CSA a plus.
• Willingness to travel for vendor/regulatory meetings.

🎁 Benefits

• Competitive compensation.
• Generous time off.
• Opportunities to attend conferences.
• Strong work-life balance.
• Collaborative, team-oriented environment.
• Impact on ultra-rare disease patients.