Job Description
📋 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.
