Associate Director, GMP Quality Assurance

Immunic Therapeutics

10d•$160,000 - $210,000

About The Position

Immunic Therapeutics is seeking an Associate Director, GMP Quality Assurance to provide quality oversight of outsourced drug substance and drug product manufacturing, testing, and supply, and to build GMP quality systems needed for commercial launch. Reporting to the Head of Quality, this role leads a small, hands-on team that will grow with the program and works closely with CMC, Supply Chain, Regulatory Affairs, Clinical Operations, contract manufacturers, and laboratories in the US and Europe. The position supports vidofludimus calcium as it advances through phase 3 toward a potential marketing application, maturing clinical-stage quality oversight into a commercial-ready, inspection-ready program. The ideal candidate brings deep GMP expertise and hands-on CDMO oversight, along with the judgment to build pragmatic, scalable systems in a lean, outsourced organization.

Requirements

Bachelor's degree in chemistry, pharmacy, biology, engineering, or a related scientific discipline.
10+ years of GMP experience in the pharmaceutical or biotechnology industry, including 5+ years in Quality Assurance.
Demonstrated experience overseeing CDMOs and contract laboratories, including batch record review, deviation and CAPA management, and batch disposition.
Strong knowledge of US and EU GMP requirements, including 21 CFR Parts 210/211 and Part 11, EU GMP Annexes 13 and 16, and ICH Q7, Q9, and Q10.
Direct involvement in at least one regulatory GMP inspection.
Experience writing quality agreements and conducting GMP audits.
Excellent communication and influencing skills, and ability to work hands-on and independently in a lean, matrixed organization with external partners.
Ability to travel up to 25%, including to partner sites in Europe.

Nice To Haves

Experience supporting a first commercial launch, including process validation, pre-approval inspections, and marketing application CMC content.
Experience with small-molecule drug substance and oral solid dosage forms.
Experience building quality systems in a small or virtual company.
Familiarity with an eQMS such as Veeva.

Responsibilities

Lead GMP quality oversight of contract manufacturers, testing laboratories, packagers, and distributors for drug substance and drug product, serving as the primary QA contact for assigned partners.
Review and approve master and executed batch records, deviations, investigations, change controls, and CAPAs; perform batch disposition for clinical supply in the US and EU, including support for Qualified Person certification.
Build the commercial quality framework, including commercial batch release, annual product quality reviews, complaint handling, recall readiness, and stability program oversight.
Provide QA oversight of process performance qualification, analytical method validation and transfer, and other launch-critical activities at partner sites.
Drive readiness for pre-approval inspections through gap assessments, mock inspections, and inspection-day support with internal teams and partners.
Author, negotiate, and maintain quality agreements that define GMP responsibilities, updating them as programs move from clinical to commercial supply.
Plan and conduct supplier qualification and periodic GMP audits, and drive audit observations to timely closure.
Develop and improve risk-based GMP procedures and quality system processes, including deviation, CAPA, change control, document control, and training processes, scaled for an outsourced model.
Partner with CMC, Supply Chain, Regulatory Affairs, and Clinical Operations to keep supply on schedule, and provide quality input to CMC sections of regulatory submissions.
Track and report quality metrics and partner performance, and escalate compliance risks to leadership with clear recommendations.