Director, Quality Management Systems — Commercial Readiness

Immunic Inc.; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Immunic Therapeutics seeks an Associate Director/Director, Quality Management Systems (QMS) to own and mature the GxP quality management system as the company advances toward commercialization. You will lead a small team and partner with CMC/Manufacturing, Clinical Operations, R&D QA, Regulatory Affairs, IT, Supply Chain and external CDMOs/CROs across the US and Europe.

The role involves building an inspection-ready QMS ahead of marketing applications, with emphasis on risk-based CSA, 21 CFR

Qualifications

• Bachelor’s degree in a scientific, engineering or related discipline (or equivalent).
• 10+ years pharma/biotech experience; 7+ years QA and 3+ years owning QMS; 12+ years with people leadership at Associate Director level.
• Hands-on with deviations, investigations, CAPA, change control, document control and GxP training in GMP environments.
• Experience implementing or administering an eQMS and applying CSV/CSA principles (21 CFR Part 11, EU Annex 11).
• Knowledge of 21 CFR 210/211, EU GMP, ICH Q7, Q9(R1), Q10; outsourcing with CDMOs/CROs.

Responsibilities

• Own the GxP quality management system end-to-end.
• Lead readiness activities and roadmaps for FDA, EU GMP and ICH/Q9(Q10) ahead of NDA/pre-approval inspections.
• Manage quality events end-to-end: deviations, OOS/OOT, investigations and root cause analyses.
• Oversee CAPA and change control, including effectiveness checks and trend analysis.
• Lead the GxP training program: curricula, LMS/eQMS, and metrics linking training to investigations.
• Oversee computer system validation and transition to risk-based CSA per relevant regulations.
• Select, implement, and validate an electronic QMS; partner with IT for launch-critical systems.
• Manage document control and build commercial quality processes (APR/PQR, complaints, recalls).
• Champion data integrity (ALCOA+) across paper and electronic records; audit trails and system reviews.
• Support inspection readiness, mock inspections, SME prep, regulatory inspections, and internal audits.

Skills

Communication skills

Leadership

Influencing skills

Education

Bachelor’s degree in a scientific, engineering or related discipline

Advanced degree

ASQ certification (CQA, CQE or CMQ/OE)

Tools

LMS/eQMS administration

eQMS

Job description

Immunic Therapeutics seeks an Associate Director/Director, Quality Management Systems (QMS) to own and mature the GxP quality management system as the company advances toward commercialization. You will lead a small team and partner with CMC/Manufacturing, Clinical Operations, R&D QA, Regulatory Affairs, IT, Supply Chain and external CDMOs/CROs across the US and Europe.

The role involves building an inspection-ready QMS ahead of marketing applications, with emphasis on risk-based CSA, 21 CFR