Senior Quality Engineering Leader GMP Compliance

Civica Rx; Petersburg (VA); On-site; USD 130,000 - 210,000; Full time

Job summary

Civica Rx is seeking a senior quality oversight leader to ensure cGMP compliance across engineering, manufacturing, and technical support functions in a sterile injectable context. The role emphasizes QMS governance, inspections readiness, and timely approvals of QA records and investigations.

The candidate will lead cross-functional teams, influence regulatory strategy, and drive continuous improvement in quality systems to support safe, reliable product supply.

Qualifications

• Bachelor's degree in a scientific discipline with extensive quality/cGMP experience.
• Experience translating FDA/EMA requirements into operations.
• Strong project management and multi-project execution skills.

Responsibilities

• Provide leadership to Quality Engineering and related departments to ensure competence and safe operations.
• Establish and maintain GMP-compliant quality system processes across facilities, equipment, and manufacturing.
• Review and approve QMS records, investigations, protocols, reports, and system deliverables.

Skills

Quality management

Regulatory compliance

Project management

Data interpretation

Education

Bachelor's degree in a scientific discipline

Job description

Civica Rx is seeking a senior quality oversight leader to ensure cGMP compliance across engineering, manufacturing, and technical support functions in a sterile injectable context. The role emphasizes QMS governance, inspections readiness, and timely approvals of QA records and investigations.

The candidate will lead cross-functional teams, influence regulatory strategy, and drive continuous improvement in quality systems to support safe, reliable product supply.