Job Title: Quality Control Director
Reports to (Title): CTO
Location: Maryland facility
Exempt/Non-Exempt: Exempt
Brief Job Summary
The Quality Control (QC) Director is responsible for establishing and leading the QC function at uBriGene, overseeing all activities related to release testing, in-process control, raw material testing, stability studies, method validation/transfer, and compliance with cGMP requirements. The QC Director will work closely with cross-functional teams to ensure testing supports both viral vector and cell therapy programs, as well as GMP manufacturing operations, while maintaining the highest quality standards and regulatory compliance.
Key Responsibilities- Lead and oversee QC laboratory operations, ensuring timely and accurate execution of release, in-process, raw material, and stability testing.
- Ensure compliance with US and EU cGMP requirements, internal SOPs, and regulatory guidelines across all QC activities.
- Establish, train, and manage a high-performing QC team with a culture of accountability, continuous improvement, and quality excellence.
- Oversee analytical method qualification/validation, method transfers, and ensure readiness of assays for GMP use.
- Review, approve, and manage QC-related documentation, including SOPs, test methods, protocols, reports, and Certificates of Analysis (COAs).
- Partner with QA to support audits, inspections, deviations, CAPAs, and change control activities.
- Ensure proper laboratory systems are in place, including sample management, data integrity, LIMS, and environmental monitoring programs.
- Monitor QC laboratory performance through metrics/KPIs and drive continuous improvement initiatives.
- Partner closely with Manufacturing and Process Development teams to support GMP manufacturing activities, including in-process testing, batch release readiness, investigations, and technical troubleshooting.
- Ensure QC systems, assays, and personnel are fully aligned to support GMP production schedules and manufacturing readiness.
- Collaborate cross-functionally with Process Development, Manufacturing, QA, and Project Management to support program timelines and deliverables.
- Provide technical expertise in analytical methods relevant to viral vector and cell therapy products (e.g., qPCR, ELISA, flow cytometry, potency assays, sterility, endotoxin, mycoplasma).
- Troubleshoot analytical and technical issues as needed, ensuring robust testing performance.
- Represent QC in regulatory inspections and client audits.
Qualifications- Master’s degree or PhD in Biology, Biochemistry, Microbiology, or a related discipline.
- 10–15 years of relevant industry experience, including at least 5 years in a QC leadership/management role within GMP-regulated biologics or cell/gene therapy/CDMO environment.
- Strong knowledge of QC analytical methodologies (qPCR, ELISA, cell-based assays, flow cytometry, microbiological assays, compendial methods).
- Relevant experience supporting GMP manufacturing operations and cross-functional collaboration with Manufacturing, Process Development, and QA teams in a GMP-regulated biologics, cell/gene therapy, or CDMO environment.
- Proven track record in establishing and managing QC teams and laboratories.
- In-depth knowledge of cGMP regulations (US and EU) and hands-on experience with regulatory inspections.
- Strong leadership, organizational, and interpersonal skills with ability to work collaboratively in a fast-paced, cross-functional environment.
- Excellent verbal and written communication skills.
- Self-motivated, detail-oriented, with ability to balance multiple priorities while meeting deadlines.
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uBriGene (MA) Biosciences Inc.