GxP Quality & Compliance Manager (Remote-Ready)

Renovo-Solutions; United States; Híbrido; USD 110 000 - 165 000; Tempo integral

Resumo da oferta

Renovo Solutions is seeking a Manager, Quality and Compliance to own the ELIS program across North America, focusing on training, qualification, and records to withstand client audits and regulatory inspections. You will lead the Quality and Compliance Specialists, manage vendor qualification, deviation and CAPA processes, and ensure documentation integrity across all GxP activities.

The role requires 5+ years in quality/compliance in a GxP environment, 2+ years of leadership, a bachelor's

Qualificações

• 5+ years of experience in quality, compliance or regulatory in a GxP environment.
• 2+ years of experience leading or managing a compliance function or team.
• Bachelor’s degree in a scientific, technical or quality discipline preferred.
• Experience with CMMS and data integrity principles.

Responsabilidades

• Own the compliance review of completed maintenance, calibration and repair records.
• Ensure good documentation practices and current procedures are followed.
• Review qualification status of instruments and third-party work on GxP assets.
• Correct documentation defects before close-out and coach the team on proper close-out.
• Lead non-conformance management and CAPA across the program.
• Prepare for client audits and inspections with traceable evidence.
• Drive process improvements and training coordination across the team.

Conhecimentos

Quality management

GxP compliance

Regulatory affairs

Audits & inspections

Training coordination

Vendor qualification

CAPA investigations

CMMS experience

Formação académica

Bachelor’s degree in scientific/technical/quality discipline

Ferramentas

CMMS

Descrição da oferta de emprego

Renovo Solutions is seeking a Manager, Quality and Compliance to own the ELIS program across North America, focusing on training, qualification, and records to withstand client audits and regulatory inspections. You will lead the Quality and Compliance Specialists, manage vendor qualification, deviation and CAPA processes, and ensure documentation integrity across all GxP activities.

The role requires 5+ years in quality/compliance in a GxP environment, 2+ years of leadership, a bachelor's