Associate Director, Quality Assurance (Systems) *PC 494

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

Associate Director, Quality Assurance (Systems) *PC 494

Locations

Showing 1 location

Gaithersburg, MD 20878, USA

• On-site
• Manufacturing
• Full-Time
• Requisition #: ASSOC003650

Description

Your Role:

The Associate Director, Quality Systems develops, maintains, and improves the Quality Management system, supporting Technical Operations, Quality, and Clinical Development/Operations.

This individual plays an integral role in ensuring internal operations, processes and systems of the Quality department are flexible, functionable, and meet phase-appropriate compliance standards. This is a cross-functional role who serves as the primary liaison to internal and external customers for all Quality system related items associated with GMP and clinical operations.

The role will serve as subject matter expert on Quality Management Systems that will help power Bioindustry technology’s continued success.

Essential Duties and Responsibilities:

• Lead, mentor, and develop a team of Quality Assurance Specialists through coaching, performance management, goal setting, and professional development activities.

Quality Systems & Governance

• Lead Quality Systems and GxP Compliance operations, including Document Control, Training, Change Control, Deviations, OOS/OOT, CAPA, Risk Management and Product Complaint support.
• Develops flexible, phase appropriate site quality systems and processes applying processes and standards in alignment with the organization’s strategy.
• Build and maintain quality programs and the internal Quality Management System. Responsible for electronic QMS deployment, administration, operation, and improvement. Communicates with other departments to resolve issues, identify and close gaps, and ensure ease of use of the QMS for personnel.
• Work with IT and external support services to configure the system over time as quality processes mature.
• Oversee the Change Control Review Board, CAPA Review Board and Management Reviews.
• Drive continuous improvement across vendor and internal quality systems, incorporating outcomes from Quality Management Review activities.
• Ensure all site-related quality documentation and records are completed thoroughly and in a timely way to maintain compliance.

Vendor & Quality Agreement Management

• Manage external oversight of GxP vendor quality systems.
• Author, maintain, and approve Quality Agreements with GxP vendors.

Audits & Inspection Readiness

• Lead internal and external GxP audit programs.
• Develop an audit plan, prepare audit reports, communicate findings, audit responses, compliance gap assessments including assessment of compliance risk to support key site stakeholders.
• Oversee inspection readiness activities, including mock audits and SME preparation.
• Support and host regulatory inspections and client audits. Interact with