Associate Director – Quality Management Systems

🕒 il y a 3 jours

🇺🇸 États-Unis – Télétravail

💵 $160 000 - $210 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 3%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Immunic Therapeutics

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2016

🏥 Santé

💼 Conseil

⚖️ Juridique

Healthcare • Consulting • Legal

Immunic Therapeutics est une entreprise de biotechnologie en phase avancée, spécialisée dans le développement de thérapies novatrices à petites molécules administrées par voie orale pour les maladies inflammatoires chroniques et auto-immunes, avec des programmes ciblant particulièrement la sclérose en plaques et la maladie cœliaque. L'entreprise fait progresser des programmes cliniques différenciés (par exemple, vidofludimus calcium, IMU-856, IMU-381) visant à fournir des options de traitement orales efficaces, sûres et bien tolérées pour les affections neurologiques et gastro-intestinales à médiation immune, tout en poursuivant des protections réglementaires et des voies de commercialisation.

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

🎯 Exigences

• 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

🏖️ Avantages

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

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