Immunic Therapeutics

Director

• Own and mature Immunic’s GxP quality management system as the company moves from late-stage clinical development toward commercialization
• Help with commercial-readiness gap assessment and roadmap against FDA, EU GMP and ICH Q9(R1)/Q10 expectations ahead of NDA submission and pre-approval inspection
• Own quality event management end to end, including deviations, OOS/OOT results, laboratory and partner-reported events, investigations and root cause analysis
• Own CAPA and change control processes, including effectiveness checks, and trend quality events across sites and partners
• Lead the GxP training program, including role-based curricula, training matrices, LMS/eQMS administration and compliance metrics
• Own the computer system validation program and drive transition to risk-based computer software assurance
• Lead selection, implementation and validation of an electronic QMS and serve as its business system owner
• Own document control and help build commercial quality processes such as APR/PQR, complaint handling and recall procedures
• Champion data integrity (ALCOA+) across paper and electronic records
• Work on inspection readiness, including mock inspections and SME preparation, and support regulatory inspections, partner audits and the internal audit program through closure of commitments
• Define QMS metrics and present Quality Management Review inputs to leadership
• Lead, coach and develop QMS staff and consultants as the function grows
• Partner with CMC/Manufacturing, Clinical Operations, R&D QA, Regulatory Affairs, IT, Supply Chain and external CDMOs, CROs and laboratories across the US and Europe

Explore Associate Director – Quality Management Systems at Immunic Therapeutics. Review requirements and application details.

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Associate Director – Quality Management Systems