ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.
We are seeking an experienced CQV & Quality Compliance Consultant to support qualification and compliance activities within regulated life sciences manufacturing environments onsite in Durham, NC. The successful candidate will perform comprehensive CQV assessments of existing facilities, utilities, equipment, and computerized systems, evaluate compliance against regulatory and industry standards, identify potential gaps, and develop practical remediation strategies. This role will also provide Quality Assurance oversight throughout CQV lifecycle activities while ensuring alignment with current GMP requirements and GAMP 5 methodologies.
Job Duties:
- 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 corrective and preventive actions (CAPA) arising from assessment findings.
- Provide QA oversight for CQV lifecycle activities
- Review and approve qualification protocols, reports, discrepancies, and deviations.
- Ensure qualification activities are executed in accordance with approved procedures and GMP expectations.
- Participate in internal audits, inspections, and quality reviews as needed.
Education and Qualifications:
- 5-10 years of experience in Quality Assurance (QA), Commissioning, Qualification & Validation (CQV), and GMP-regulated pharmaceutical, biotechnology, or medical device environments.
BENEFITS:
What We Offer:
Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.
