GMP QA Director — Commercial Launch Readiness (Outsourced)

Immunic Therapeutics; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

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 scalable GMP quality systems for commercial launch.

Reporting to the Head of Quality, you will lead a hands-on team and partner with CMC, Regulatory Affairs, Clinical Operations, and contract manufacturers in the US and Europe to advance a phase 3 program toward a potential marketing application.

Qualifications

• Bachelor's degree in a scientific discipline; 10+ years GMP experience and 5+ years QA leadership in pharma/biotech.
• Experience overseeing CDMOs and contract laboratories with batch records, deviations, CAPA, and batch disposition.
• Strong knowledge of US/EU GMP requirements, regulatory inspections, and quality agreements.

Responsibilities

• Provide quality oversight of outsourced manufacturing, testing and supply for drug substance and drug product.
• Lead QA interactions with contract manufacturers and labs in US/Europe; prepare for inspections.
• Develop and mature GMP quality systems for commercial readiness and routine release.
• Oversee process validation, analytical method validation/transfer, and transfer to partners.
• Plan and execute supplier qualification and audits; drive closure of audit observations.
• Collaborate with CMC, Regulatory Affairs, Clinical Operations, and Supply Chain to align quality activities with program milestones.
• Track quality metrics and escalate risks with recommendations to leadership.

Skills

GMP QA oversight

CDMO oversight

Regulatory inspections

Quality systems

Quality metrics

Cross-functional collaboration

Risk-based thinking

Strong communication

Education

Bachelor's degree in chemistry, pharmacy, biology, engineering or related discipline

Tools

eQMS (Veeva)

Job description

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 scalable GMP quality systems for commercial launch.

Reporting to the Head of Quality, you will lead a hands-on team and partner with CMC, Regulatory Affairs, Clinical Operations, and contract manufacturers in the US and Europe to advance a phase 3 program toward a potential marketing application.