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Goldbelt Apex LLC · 6 hours ago

Quality Manager

Fort Detrick, MD

Full-time

Onsite

Senior Level, Lead/Staff

$150K/yr - $185K/yr

8+ years exp

Goldbelt Apex LLC is a data-focused company dedicated to process and quality in healthcare IT. The Quality Manager will lead the implementation of quality assurance programs to ensure compliance with GLP, ISO, and DoD regulatory requirements, while overseeing quality systems in support of research and diagnostics.

Responsibilities

Develop, implement, and monitor quality control processes

Conduct internal audits and corrective action reviews

Train personnel on QA policies and GLP principles

Maintain SOPs and QA/QC documentation systems

Coordinate inspections and regulatory reporting

Qualification

GLP regulationsISO 9001/13485FDA/DoD regulationsCAPA managementRoot cause analysisProcess improvementQuality assurance degreeASQ certificationLeadership skillsCommunication skillsTeamwork

Required

Knowledge of GLP, ISO 9001/13485, and FDA/DoD regulations

Strong auditing and root cause analysis skills

Experience with CAPA and deviation management

Excellent leadership and process improvement skills

Shall have the ability to analyze these extremely complex problems and recommend, monitor and execute best practice solutions to executive level management

Possesses good written and oral communication skills, along with the ability to work well in teams

Bachelor's degree in quality assurance, regulatory science, or life sciences

Minimum 8+ years in quality systems in biomedical or regulatory environments

Ability to obtain and maintain a SECRET security clearance eligibility, with no access to classified information, is required

Enroll in the Personnel Reliability Program (PRP), if required