GMP QA Director for Commercial Launch Readiness

Immunic Inc.; United States; Remote; USD 180,000 - 250,000; Full time

Job summary

Immunic Therapeutics seeks an Associate Director, GMP Quality Assurance to provide quality oversight of outsourced manufacturing, testing, and supply. You will build GMP quality systems for a commercial launch and lead a hands-on QA team working with US/EU partners.

The ideal candidate has deep GMP expertise, hands-on CDMO oversight, and experience maturing a lean, outsourced quality program toward commercial readiness. Travel up to 25% is expected.

Qualifications

• Bachelor's degree in chemistry, pharmacy, biology, engineering, or related field.
• 10+ years GMP experience in pharma/biotech, with 5+ years in QA.
• Experience overseeing CDMOs and contract labs, with batch record review and CAPA.
• Deep knowledge of US/EU GMP requirements (21 CFR Parts 210/211, Part 11; EU GMP).
• Regulatory GMP inspection experience and writing quality agreements.
• Strong communication and ability to work hands-on in a lean, outsourced org.
• Travel up to 25%, including to Europe.
• Experience supporting first commercial launch; process validation preferred.
• Experience with small-molecule drug substance and oral solids preferred.
• Experience building quality systems in small/virtual companies; familiarity with eQMS (Veeva).

Responsibilities

• Lead GMP quality oversight of contract manufacturers, testing laboratories, packagers and distributors for drug substance and product.
• Review and approve batch records, deviations, investigations, CAPAs, and batch disposition for clinical supply in US and EU.
• Build the commercial quality framework, including commercial batch release and annual PQRs.
• Provide QA oversight of process qualification, analytical method validation and transfer for launch-critical activities.
• Drive readiness for pre-approval inspections and mock inspections with internal teams and partners.
• Author, negotiate and maintain quality agreements for GMP responsibilities across programs.
• Plan supplier qualification and periodic GMP audits; close audit observations timely.
• Develop and improve risk-based GMP procedures and quality system processes for outsourced model.
• Collaborate with CMC, Supply Chain, Regulatory Affairs and Clinical Operations to keep supply on schedule.
• Track and report quality metrics and elevate compliance risks with recommendations.

Skills

GMP QA leadership

CDMO oversight

Regulatory inspections

Quality metrics & CAPA

Vendor qualification

Cross-functional collaboration

Education

Bachelor's degree in chemistry/biology/engineering

Tools

Veeva

Job description

Immunic Therapeutics seeks an Associate Director, GMP Quality Assurance to provide quality oversight of outsourced manufacturing, testing, and supply. You will build GMP quality systems for a commercial launch and lead a hands-on QA team working with US/EU partners.

The ideal candidate has deep GMP expertise, hands-on CDMO oversight, and experience maturing a lean, outsourced quality program toward commercial readiness. Travel up to 25% is expected.