Associate Director, GMP Quality Assurance

Immunic Therapeutics

. Provide quality oversight of outsourced drug substance and drug product manufacturing, testing and supply .

Posted 10/31/2026full-timeRemote • United StatesSenior💰 $160,000 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in GMP quality oversight, including batch record review, deviation management, and regulatory compliance in the pharmaceutical industry. Proven ability to lead quality teams and build robust quality systems while ensuring adherence to US and EU regulations.

Highest-signal resume keywords

GMP Quality OversightBatch Record ReviewRegulatory ComplianceQuality Agreement WritingGMP Auditing

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

GMP ExperienceDeviation ManagementCAPA ManagementBatch DispositionAnalytical Method ValidationProcess Performance QualificationRisk-Based GMP ProceduresQuality System ProcessesRegulatory GMP InspectionCommercial Launch Support

Soft Skills

Excellent Communication SkillsInfluencing SkillsIndependent Work AbilityTeam Leadership

Tools & Technologies

EQMSVeeva

Certifications & Qualifications

Qualified Person Certification

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryCDMO OversightUS GMP RequirementsEU GMP Requirements21 CFR Parts 210/211ICH Q7ICH Q9ICH Q10Oral Solid Dosage Forms

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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