Associate Director/Director, Quality Management Systems (QMS)

Immunic Inc.; United States; À distance; USD 180 000 - 240 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Communication skills

Leadership

Influencing skills

Formation

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

Advanced degree

ASQ certification (CQA, CQE or CMQ/OE)

Outils

LMS/eQMS administration

eQMS

Description du poste

Summary

We are seeking an Associate Director/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

Immunic Therapeutics is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Please note, Immunic does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Immunic and the agency. Immunic will not pay any fees related to unsolicited resumes.