The posting
Summary
We are seeking an Associate Director, GMP Quality Assurance to provide quality oversight of our outsourced drug substance and drug product manufacturing, testing and supply, and to build the GMP quality systems needed for commercial launch.
Reporting to the Head of Quality, you will lead a small, hands-on team that will grow with the program, and partner closely with CMC, Supply Chain, Regulatory Affairs and Clinical Operations, as well as our contract manufacturers and laboratories in the US and Europe.
You will join us as vidofludimus calcium advances through phase 3 toward a potential marketing application, when clinical-stage quality oversight must mature into a commercial-ready, inspection-ready program. The ideal candidate combines deep GMP expertise and hands-on CDMO oversight with the judgment to build pragmatic, scalable systems in a lean, outsourced organization.
Responsibilities
- Lead GMP quality oversight of contract manufacturers, testing laboratories, packagers and distributors for drug substance and drug product, serving as the primary QA contact for assigned partners.
- Review and approve master and executed batch records, deviations, investigations, change controls and CAPAs, and 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 at partner sites.
- Drive readiness for pre-approval inspections, leading gap assessments, mock inspections and inspection-day support with internal teams and partners.
- Author, negotiate and maintain quality agreements that clearly define GMP responsibilities, and update them as programs move from clinical to commercial supply.
- Plan and conduct supplier qualification and periodic GMP audits, and drive audit observations to timely closure.
- Develop and improve risk-based GMP procedures and quality system processes (deviation, CAPA, change control, document control, training) scaled for an outsourced model.
- Partner with CMC, Supply Chain, Regulatory Affairs and Clinical Operations to keep supply on schedule, and provide quality input to the CMC sections of regulatory submissions.
- Track and report quality metrics and partner performance, and escalate compliance risks to leadership with clear recommendations.
Qualifications & Education
- 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.
- Demonstrated 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, and 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, and familiarity with an eQMS such as Veeva, preferred.
Immunic Therapeutics is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
Please note, Immunic does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Immunic and the agency. Immunic will not pay any fees related to unsolicited resumes.
