Lead, Quality Systems & Compliance (Associate Director)

Lentigen-Technology-Inc.; Gaithersburg (MD); On-site; USD 140,000 - 190,000; Full time

Job summary

Lentigen Technology Inc. in Gaithersburg, MD is seeking an Associate Director of Quality Assurance (Systems) to lead the Quality Management System, drive GxP compliance, and partner with Clinical Operations and IT.

This role focuses on governance, optimization, and cross-functional collaboration to ensure phase-appropriate quality controls. The position involves directing a QA team, implementing robust QMS processes, and coordinating with external vendors and regulatory bodies to maintain

Qualifications

• Experience leading QA teams in GMP/clinical operations.
• Knowledge of Quality Management System deployment and maintenance.
• Experience with CAPA, Change Control, Deviations, OOS/OOT, Risk Management.

Responsibilities

• Lead, mentor, and develop a team of Quality Assurance Specialists.
• Lead Quality Systems and GxP Compliance operations including Document Control, Training, Change Control, Deviations, OOS/OOT, CAPA, Risk Management and Product Complaint support.
• Develop flexible site quality systems and processes aligned with the organization’s strategy.
• Manage external oversight of GxP vendor quality systems and Quality Agreements.
• Lead internal and external GxP audit programs and prepare reports.
• Oversee inspection readiness activities and host regulatory inspections and client audits.

Skills

Leadership

Quality systems

GxP compliance

Cross-functional collaboration

Mentoring

Tools

QMS software

Document Control systems

CAPA system

Job description

Lentigen Technology Inc. in Gaithersburg, MD is seeking an Associate Director of Quality Assurance (Systems) to lead the Quality Management System, drive GxP compliance, and partner with Clinical Operations and IT.

This role focuses on governance, optimization, and cross-functional collaboration to ensure phase-appropriate quality controls. The position involves directing a QA team, implementing robust QMS processes, and coordinating with external vendors and regulatory bodies to maintain