Clinical QA Manager: Regulatory Audits & Process Improvement

The General Hospital Corporation; Somerville (MA); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

The General Hospital Corporation, through the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital, seeks a Quality Assurance Manager to drive QA initiatives for regulatory compliance, SOPs, and audits across multi-site clinical research programs.

You will work under supervision of senior QA leadership, coordinating with study teams, regulatory authorities, and industry sponsors to ensure study quality and compliance with GCP and institutional policies.

Competenze

• Strong organizational and communication skills.
• Demonstrated analytical skills.
• Effective problem solving skills.
• Ability to supervise and train staff effectively.
• Strong database management and computer skills.
• Must possess aptitude for budget management.

Mansioni

• Audit NCRI projects for adherence to policies, SOPs and GCP.
• Coordinate QA activities with NCRI study teams and regulatory bodies.
• Prepare for external audits/inspections and respond to audit findings.
• Draft and revise NCRI policies and SOPs; ensure inspections readiness.
• Oversee QA tasks per the NCRI Quality Management Plan and CAPAs.
• Lead internal reviews of staff adherence and training effectiveness.

Conoscenze

Organizational skills

Communication skills

Analytical skills

Staff supervision

Database management

Budget management

Formazione

Bachelor's Degree (related field)

Master's Degree (related field) preferred

Descrizione del lavoro

The General Hospital Corporation, through the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital, seeks a Quality Assurance Manager to drive QA initiatives for regulatory compliance, SOPs, and audits across multi-site clinical research programs.

You will work under supervision of senior QA leadership, coordinating with study teams, regulatory authorities, and industry sponsors to ensure study quality and compliance with GCP and institutional policies.