Director, Quality Assurance

Location :

• Remote  Job Type : Full-time, Exempt  Reports to : Chief Executive Officer  Join Us at Civia Health  The Director, Quality Assurance (CQA) will oversee quality assurance activities to ensure compliance with Good Clinical Practice (GCP), applicable regulations, and company SOPs.
• The role involves performing internal and site audits, hosting sponsor audits, overseeing Corrective and Preventive Actions (CAPA), drafting and maintaining SOPs, ongoing consultative support, and ensuring inspection readiness.

This position will also establish, track, and report on key performance indicators (KPIs) related to quality compliance and audit readiness.  At Civia Health, you're not just taking a job :

Our purpose is bold :

We're looking for people who are driven by purpose, inspired by innovation, and ready to roll up their sleeves to do meaningful work.   At Civia, your contributions aren’t just transactional, they’re transformational .  What You’ll Do  Provide quality oversight of clinical trial activities to ensure compliance with GCP, regulatory requirements, and company SOPs.  Develop and implement quality assurance strategies to support continuous improvement across clinical operations with an emphasis on improving efficiency and compliance.   Lead inspection readiness initiatives and serve as the primary point of contact during sponsor audits and regulatory inspections.  Host and manage sponsor audits at the SMO, including coordinating logistics, preparing staff, and ensuring timely document provision.  Oversee audit follow-up activities, including drafting and reviewing responses, and ensure timely CAPA closure.  Lead the development, implementation, and effectiveness checks of CAPA plans arising from audits, inspections, or quality issues.  Ensure CAPAs are tracked, resolved, and documented in compliance with internal timelines and regulatory requirements.  Draft, review, and maintain SOPs to ensure alignment with GCP, regulations, and best practices.  Support the continuous improvement of the quality management system.  Define, track, and report KPIs related to quality assurance activities (e.g., CAPA closure timelines, audit / inspection readiness scores, SOP compliance rates).  Act as a key point of contact for quality-related inquiries from sponsors and internal stakeholders.    What You Bring  Bachelor’s degree in life sciences, pharmacy, nursing, or related field (advanced degree preferred).  Minimum 5 years of clinical research experience within Site, CRO, or sponsor settings (experience in clinical QA required).  Experience hosting sponsor audits and preparing for regulatory inspections is strongly preferred.  Experience in CAPA management, SOP development, and quality system implementation.  Experience with KPI development, tracking, and reporting is an advantage.  Willingness to travel occasionally to other sites for study support.  Comprehensive understanding of ICH-GCP, 21 CFR Parts 11, 50, 56, 312, 812, HIPAA, and applicable FDA regulations.  Strong understanding of ICH-GCP, relevant FDA regulations, and clinical trial processes.  Strong knowledge of regulatory requirements for both U.S. and international clinical research preferred.  Excellent organizational, communication, and leadership skills.  Ability to lead cross-functional teams and manage multiple projects in a fast-paced environment.  Strong problem-solving and decision-making abilities.  Detail-oriented with a high standard for quality and compliance.  Self-motivated and strong work ethic   Strong time management skills  Ability to adapt, multi-task and prioritize  Teamwork and Communication  What We Offer  Competitive compensation  Medical, dental, and vision insurance  Generous PTO and paid holidays  Flexible scheduling options  Professional development and continuing education support  A mission-driven team that values respect, inclusion, and innovation  Ready to Make an Impact?   Mission with Meaning :

Collaboration, transparency, and bold, straight-talking are core to how we work.  Invested in Your Growth :