Associate Director, GMP Quality Assurance
New
I
Immunic TherapeuticsBiopharmaceuticals
Remote - USFull-TimeDirector
Salary$160K - $210K; $160K – $210K • Offers Equity • Offers Bonus; Estimated Salary Range $160K – $210K • Offers Equity • Offers Bonus
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Job Details
- Experience
- 10+ years of GMP experience in the pharmaceutical or biotechnology industry, including 5+ years in Quality Assurance.
- Required Skills
- Quality Assurance
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.
- Experience with 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.
- 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.
- Preferred: 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 and familiarity with an eQMS such as Veeva.
Responsibilities
- Lead GMP quality oversight of contract manufacturers, testing laboratories, packagers and distributors, serving as the primary QA contact for assigned partners.
- Review and approve batch records, deviations, investigations, change controls and CAPAs, and perform batch disposition for clinical supply in the US and EU.
- Build the commercial quality framework, including batch release, annual product quality reviews, complaint handling, recall readiness and stability oversight.
- Oversee process performance qualification, analytical method validation and transfer, and other launch-critical partner-site activities.
- Lead inspection-readiness gap assessments, mock inspections and inspection-day support.
- Author, negotiate and maintain quality agreements defining GMP responsibilities.
- Plan and conduct supplier qualification and periodic GMP audits, and drive observations to closure.
- Develop and improve risk-based GMP procedures and quality system processes, including deviation, CAPA, change control, document control and training.
- Partner with CMC, Supply Chain, Regulatory Affairs and Clinical Operations to support supply and provide quality input to CMC regulatory submissions.
- Track and report quality metrics and partner performance, escalating compliance risks to leadership with recommendations.
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