Senior CQV QA Compliance Engineer | GMP & Regulatory Expert

ELIQUENT Life Sciences; Durham (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

ELIQUENT Life Sciences seeks an experienced CQV & Quality Compliance Consultant to support qualification and compliance activities within regulated life sciences manufacturing environments. You will perform comprehensive CQV assessments of facilities, utilities, equipment, and computerized systems, and ensure GMP alignment.

Responsibilities include reviewing qualification docs, identifying gaps, developing remediation plans, and providing QA oversight across CQV lifecycle while aligning with

Qualifications

• 5–10 years of QA, CQV, and GMP experience in regulated life sciences environments.

Responsibilities

• Conduct detailed assessments of existing manufacturing facilities, utilities, equipment, processes, and computerized systems.
• Evaluate current qualification and validation documentation for compliance with regulatory expectations.
• Perform gap assessments against applicable regulations, industry guidance, and company procedures.
• Assess the effectiveness of commissioning, qualification, and validation programs and review legacy systems and determine qualification status and compliance risks.
• Identify compliance gaps, risks, and operational deficiencies
• Develop risk-based mitigation strategies and remediation plans.
• Provide recommendations aligned with FDA, EMA, ICH, ISPE, and other applicable industry standards.
• Support implementation of CAPA arising from assessment findings.

Skills

QA experience

CQV experience

GMP experience

Job description

ELIQUENT Life Sciences seeks an experienced CQV & Quality Compliance Consultant to support qualification and compliance activities within regulated life sciences manufacturing environments. You will perform comprehensive CQV assessments of facilities, utilities, equipment, and computerized systems, and ensure GMP alignment.

Responsibilities include reviewing qualification docs, identifying gaps, developing remediation plans, and providing QA oversight across CQV lifecycle while aligning with