Associate Director – Quality Management Systems

Immunic Therapeutics

. Own and mature Immunic’s GxP quality management system as the company moves from late-stage clinical development toward commercialization .

Posted 10/30/2026full-timeRemote • United StatesSenior💰 $160,000 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in GxP Quality Management Systems, including CAPA, change control, and document control processes, while ensuring compliance with FDA, EU GMP, and ICH standards. Proven ability to lead quality assurance initiatives, manage training programs, and support regulatory inspections in a pharmaceutical or biotechnology environment.

Highest-signal resume keywords

GxP Quality Management System OwnershipCAPA and Change Control ManagementEQMS Implementation and AdministrationRegulatory Compliance (21 CFR, EU GMP, ICH)People Leadership in Quality Assurance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Event ManagementDeviation ManagementRoot Cause AnalysisDocument ControlGxP Training Program DevelopmentComputer System ValidationRisk-Based Computer Software AssuranceQuality Metrics DefinitionInspection ReadinessQuality Assurance in GMP Environment

Soft Skills

Excellent Communication SkillsInfluencing SkillsStrategic and Hands-On OperationTeam LeadershipCoaching and Development

Tools & Technologies

Electronic Quality Management System (eQMS)Learning Management System (LMS)Quality Management Review Inputs

Certifications & Qualifications

Advanced DegreeASQ Certification (CQA, CQE, CMQ/OE)

Industry Keywords

PharmaceuticalBiotechnologyGMPClinical DevelopmentCommercializationSmall-Molecule Oral Solid Dosage ProductsCDMOCRORegulatory InspectionsQuality Assurance

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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