Quality Control Director

uBriGene (MA) Biosciences Inc.•Germantown, MD

1d•Onsite

About The Position

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.

Requirements

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.

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.