Senior GxP Quality & Compliance Lead

Renovo Solutions; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Renovo Solutions is seeking a Manager of Quality and Compliance to own the ELIS program across North America. The role focuses on training, qualification, and records to withstand client audits and regulatory inspections.

You will lead a team to ensure GxP standards are met, coordinate vendor qualifications, and manage documentation quality. Responsibilities include maintaining training matrices, supervising deviation and CAPA processes, and ensuring readiness for audits.

Qualifications

• Bachelor’s degree in scientific/quality field; equivalent experience considered.
• 5+ years in quality/compliance in a GxP environment.
• 2+ years leading a compliance function.
• Experience supporting client audits and regulatory inspections.
• Training in GxP, data integrity and related standards.

Responsibilities

• Oversee training and qualification compliance for all personnel on the ELIS program across North America.
• Qualify and requalify vendors against client quality requirements.
• Review and certify completed maintenance, calibration and repair records for GxP assets.
• Lead deviation, non-conformance and CAPA processes from discovery to closure.
• Prepare for and support client audits and regulatory inspections with traceable evidence.
• Ensure processes and documents are current, accurate, and properly versioned.
• Manage the Quality & Compliance team, allocating work and driving performance.
• Escort and host third-party personnel on-site, ensuring safety and scope adherence.

Skills

Quality management

Regulatory affairs

GxP compliance

CAPA management

Training coordination

CMMS

Data integrity

Audits & inspections

Leadership

GMP/GLP/GCP

Education

Bachelor's degree in science or quality discipline

Tools

CMMS

Job description

Renovo Solutions is seeking a Manager of Quality and Compliance to own the ELIS program across North America. The role focuses on training, qualification, and records to withstand client audits and regulatory inspections.

You will lead a team to ensure GxP standards are met, coordinate vendor qualifications, and manage documentation quality. Responsibilities include maintaining training matrices, supervising deviation and CAPA processes, and ensuring readiness for audits.