SummaryWe are seeking a Senior Manager / Associate Director, Quality Management Systems (QMS) to own and mature Immunic's GxP quality management system as the company moves from late-stage clinical development toward commercialization.
Reporting to Executive Directory of Quality Assurance, you will lead core QMS processes hands-on, with a small team, and partner closely with CMC/Manufacturing, Clinical Operations, R&D QA, Regulatory Affairs, IT, Supply Chain and our external CDMOs, CROs and laboratories across the US and Europe.
You will join us as vidofludimus calcium advances through phase 3 trials in multiple sclerosis, a pivotal moment to build a commercial-ready, inspection-ready QMS ahead of marketing applications and pre-approval inspections. The ideal candidate combines deep, hands-on QMS expertise with the judgment to scale systems pragmatically and the influence to drive quality across functions and partners.
Responsibilities- Own the GxP quality management system
- Help with, as needed, 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, ensuring timely triage, risk assessment and escalation.
- Own the CAPA and change control processes, including effectiveness checks, and trend quality events across sites and partners to identify and resolve systemic issues.
- Lead the GxP training program, including role-based curricula, training matrices, LMS/eQMS administration and compliance metrics, and link training to investigation outcomes and retraining effectiveness.
- Own the computer system validation program and drive the transition to risk-based computer software assurance (CSA) aligned with 21 CFR Part 11, EU GMP Annex 11, GAMP 5 and FDA CSA guidance.
- Lead selection, implementation and validation of an electronic QMS and serve as its business system owner; partner with IT to validate launch-critical systems.
- Own document control and help build commercial quality processes, such as APR/PQR, complaint handling, recall procedures.
- Champion data integrity (ALCOA+) across paper and electronic records, including audit trail review, periodic system review and data integrity risk assessments.
- Work on, as needed, inspection readiness, including mock inspections and SME preparation, and support regulatory inspections, partner audits and the internal audit program through to 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.
- Work as assigned by leadership.
Qualifications & Education- Bachelor's degree in a scientific, engineering or related discipline or equivalent experience.
- 10+ years of pharmaceutical or biotechnology experience, including 7+ years in Quality Assurance and 3+ years owning QMS processes; 12+ years and prior people leadership for the Associate Director level.
- Hands-on experience running deviations, investigations, CAPA, change control, document control and GxP training in a GMP environment.
- Experience implementing or administering an eQMS and applying CSV/CSA principles, including 21 CFR Part 11 and EU Annex 11 requirements.
- Strong knowledge of 21 CFR 210/211, EU GMP, and ICH Q7, Q9(R1) and Q10.
- Experience managing quality in an outsourced model with CDMOs, CROs and contract laboratories.
- Excellent communication and influencing skills; ability to operate both strategically and hands-on in a lean, international matrix organization.
- Ability to travel up to 15% for partner audits and inspections.
- Experience supporting a pre-approval inspection or a company's transition from clinical to commercial preferred.
- Advanced degree or ASQ certification (CQA, CQE or CMQ/OE) preferred.
- Experience with eQMS preferred.
- Experience with small-molecule oral solid dosage products preferred.
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