Associate Director – Quality Management Systems

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership and enhance Immunic’s GxP quality management system as the organization transitions from late-stage clinical development to commercialization.

• Assist in evaluating commercial readiness and creating a roadmap in compliance with FDA, EU GMP, and ICH Q9(R1)/Q10 standards in preparation for NDA submission and pre-approval inspections.

• Manage quality event processes comprehensively, including deviations, OOS/OOT results, laboratory and partner-reported events, investigations, and root cause analysis.

• Oversee CAPA and change control procedures, including effectiveness checks, while analyzing quality events across various sites and partners.

• Lead the GxP training initiative, which includes role-specific curricula, training matrices, LMS/eQMS administration, and compliance metrics.

• Direct the computer system validation program and facilitate the transition to a risk-based approach for computer software assurance.

• Guide the selection, implementation, and validation of an electronic QMS, acting as its business system owner.

• Manage document control and assist in establishing commercial quality processes such as APR/PQR, complaint handling, and recall procedures.

• Advocate for data integrity (ALCOA+) across both paper and electronic records.

• Focus on inspection readiness through mock inspections and SME preparation, while supporting regulatory inspections, partner audits, and the internal audit program until commitments are fulfilled.

• Establish QMS metrics and provide Quality Management Review inputs to the leadership team.

• Lead, mentor, and develop QMS staff and consultants as the function expands.

• Collaborate with CMC/Manufacturing, Clinical Operations, R&D QA, Regulatory Affairs, IT, Supply Chain, as well as external CDMOs, CROs, and laboratories across the US and Europe.

⛳️ Requirements

• Bachelor’s degree in a scientific, engineering, or related field, or equivalent experience.

• Over 10 years of experience in pharmaceutical or biotechnology sectors, including more than 7 years in Quality Assurance and at least 3 years managing QMS processes.

• 12+ years of experience with prior people management experience suitable for the Associate Director level.

• Practical experience in handling deviations, investigations, CAPA, change control, document control, and GxP training within a GMP environment.

• Proven experience in implementing or managing an eQMS and applying CSV/CSA principles, including compliance with 21 CFR Part 11 and EU Annex 11 requirements.

• Strong understanding of 21 CFR 210/211, EU GMP, and ICH Q7, Q9(R1), and Q10 guidelines.

• Experience in managing quality within an outsourced model involving CDMOs, CROs, and contract laboratories.

• Exceptional communication and influencing abilities; capable of operating both strategically and practically within a lean, international matrix organization.

• Willingness to travel up to 15% for partner audits and inspections.

• Prior experience supporting a pre-approval inspection or facilitating a company's transition from clinical to commercial operations is preferred.

• An advanced degree or ASQ certification (CQA, CQE, or CMQ/OE) is preferred.

• Experience with eQMS is preferred.

• Familiarity with small-molecule oral solid dosage products is preferred.

• Authorization to work in the US is required.

🏝️ Benefits

• Equity

• Bonus

• Remote work arrangement

• Up to 15% travel for partner audits and inspections