GMP QA Lead – Cell Therapy Operations

Clinical Dynamix, Inc.; Germantown (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Clinical Dynamix, Inc. seeks a Quality Assurance Manager, GMP Operations to lead quality assurance for clinical cell-therapy manufacturing.

You will own GMP operations quality on the floor, drive batch disposition, deviations, CAPA, and change control while partnering with Manufacturing, QC, and Analytical Development. You will mentor QA staff, oversee SOPs and document control, and maintain an effective eQMS to ensure cGMP compliance as the company advances toward later-stage clinical

Qualifications

• Bachelor’s degree in a scientific, technical, or regulatory discipline.
• 8+ years in a cGMP environment with progressive QA responsibilities.
• Experience leading QA functions: batch review/release, deviations/CAPA, change control, audits/inspections.
• Strong knowledge of cGMP and FDA regulations for cell and gene therapies.
• Proficiency with eQMS and QC data workflows.
• Experience with risk assessments (FMEA) and supplier quality oversight.

Responsibilities

• Own GMP operations quality for in-house cell-therapy manufacturing, serving as the primary QA contact on the manufacturing floor (Quality on the Floor).
• Lead technical review of Batch Manufacturing Records, logbooks, QC testing records, and validation/calibration documentation.
• Support and coordinate product disposition and release activities with the quality release authority.
• Provide QA oversight for raw material, in-process, and sample release decisions and QC sample submission workflows.
• Own and manage deviations and investigations; lead root-cause analysis and drive CAPA plans to closure.
• Lead and coordinate change controls (assessment, approval, verification) and risk assessments across manufacturing programs.
• Author, revise, and approve SOPs and quality documents; manage document lifecycle and training in the document control system.
• Maintain and improve the eQMS and associated records.
• Establish, track, and analyze QA metrics and trends; present actionable insights to leadership.
• Serve as a primary QA lead for internal and external audits and regulatory inspections; prepare responses and corrective actions.

Skills

Leadership

Quality judgment

Risk assessment

Problem solving

Communication

Time management

Education

Bachelor's degree in a scientific/technical/regulatory field

Tools

LIMS

eQMS

Job description

Clinical Dynamix, Inc. seeks a Quality Assurance Manager, GMP Operations to lead quality assurance for clinical cell-therapy manufacturing.

You will own GMP operations quality on the floor, drive batch disposition, deviations, CAPA, and change control while partnering with Manufacturing, QC, and Analytical Development. You will mentor QA staff, oversee SOPs and document control, and maintain an effective eQMS to ensure cGMP compliance as the company advances toward later-stage clinical