Associate Director, GMP Quality Assurance

🔥 17 hours ago

🇺🇸 United States – Remote

💵 $160k - $210k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 3%

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Immunic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

🏥 Healthcare

💼 Consulting

⚖️ Legal

Healthcare • Consulting • Legal

Immunic Therapeutics is a late-stage biotechnology company focused on developing novel, orally administered small-molecule therapies for chronic inflammatory and autoimmune diseases, with particular programs targeting multiple sclerosis and celiac disease. The company advances differentiated clinical-stage programs (e. g. , vidofludimus calcium, IMU-856, IMU-381) aiming to provide efficacious, safe, and well-tolerated oral treatment options for neurologic and gastrointestinal immune-mediated conditions, while pursuing regulatory protections and commercialization pathways.

📋 Description

• Provide quality oversight of outsourced drug substance and drug product manufacturing, testing and supply • Lead a small, hands-on quality team • Lead GMP quality oversight of contract manufacturers, testing laboratories, packagers and distributors • 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 • Drive readiness for pre-approval inspections through gap assessments, mock inspections and inspection-day support • Author, negotiate and maintain quality agreements • Plan and conduct supplier qualification and periodic GMP audits, and drive audit observations to closure • Develop and improve risk-based GMP procedures and quality system processes • Partner with CMC, Supply Chain, Regulatory Affairs and Clinical Operations to keep supply on schedule and provide quality input to regulatory submissions • Track and report quality metrics and partner performance, escalating compliance risks to leadership

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

🏖️ Benefits

• Equity • Bonus • Remote work arrangement • Equal Opportunity Employer commitment to a diverse, inclusive, and equitable workplace

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