Senior Manager / Associate Director, GMP Quality Assurance
About The Position
Immunic is seeking a Senior Manager / Associate Director, Quality Management Systems (QMS) to own and mature its GxP quality management system as the company advances from late-stage clinical development toward commercialization. Reporting to the Executive Director of Quality Assurance, this hands-on role leads core QMS processes with a small team and partners with CMC/Manufacturing, Clinical Operations, R&D QA, Regulatory Affairs, IT, Supply Chain, and external CDMOs, CROs, and laboratories across the US and Europe. The role will help build a commercial-ready, inspection-ready QMS as vidofludimus calcium advances through Phase 3 trials in multiple sclerosis and ahead of marketing applications and pre-approval inspections. The successful candidate brings deep practical QMS expertise, sound judgment in scaling systems pragmatically, and the ability to influence quality across functions and partners. Travel of up to 15% is expected for partner audits and inspections.
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.
- For the Associate Director level, 12+ years of experience and prior people leadership.
- 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, and ability to work strategically and hands-on in a lean, international matrix organization.
- Ability to travel up to 15% for partner audits and inspections.
Nice To Haves
- Experience supporting a pre-approval inspection or a company’s transition from clinical to commercial.
- Advanced degree or ASQ certification (CQA, CQE, or CMQ/OE).
- Experience with eQMS.
- Experience with small-molecule oral solid dosage products.
Responsibilities
- Own the GxP quality management system and, as needed, help assess commercial-readiness gaps and develop a roadmap against FDA, EU GMP, and ICH Q9(R1)/Q10 expectations ahead of NDA submission and pre-approval inspection.
- Own end-to-end quality event management, including deviations, OOS/OOT results, laboratory and partner-reported events, investigations, and root cause analysis; ensure timely triage, risk assessment, and escalation.
- Own 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; connect training to investigation outcomes and retraining effectiveness.
- Own the computer system validation program and drive 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, and recall procedures.
- Champion ALCOA+ data integrity across paper and electronic records, including audit trail review, periodic system review, and data integrity risk assessments.
- Work on inspection readiness as needed, including mock inspections and SME preparation; 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.
- Perform other work as assigned by leadership.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
