Associate Director – Quality Management Systems

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $160k - $210k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 1%

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Immunic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

🏥 Healthcare

💼 Consulting

⚖️ Legal

Healthcare • Consulting • Legal

Immunic Therapeutics is a late-stage biotechnology company focused on developing novel, orally administered small-molecule therapies for chronic inflammatory and autoimmune diseases, with particular programs targeting multiple sclerosis and celiac disease. The company advances differentiated clinical-stage programs (e. g. , vidofludimus calcium, IMU-856, IMU-381) aiming to provide efficacious, safe, and well-tolerated oral treatment options for neurologic and gastrointestinal immune-mediated conditions, while pursuing regulatory protections and commercialization pathways.

📋 Description

• 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

🎯 Requirements

• 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 • Authorization to work in the US

🏖️ Benefits

• Equity • Bonus • Remote work arrangement • Up to 15% travel for partner audits and inspections

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