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Director, Clinical Quality Assurance

Director, Clinical Quality Assurance

Civia HealthPhiladelphia, PA, US
17 days ago
Job type
  • Full-time
  • Quick Apply
Job description

Location :

  • Remote  Job Type : Full-time, Exempt  Reports to : Chief Executive Officer  Join Us at Civia Health  The Director, Clinical 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 :

  • You're joining a mission to transform the way clinical research is done.

    • Our purpose is bold :

  • to bring clinical trials front and center in your community, make them accessible to everyday people, and empower underrepresented communities to participate.  We’re reinventing how clinical studies are run, delivering valid, scalable evidence with a consumer-first mindset.
  • Too often, trials are expensive, fragmented, and overlook the experience of the participant.
  • At Civia, we’re changing that.
  • Our leadership team are experienced industry leading, visionary professionals who know what’s broken — and how to fix it.  We treat participants like valued partners, not research subjects.
  • That means supporting their agency, putting their needs, comfort, and enjoyment first — and rewarding them generously for their time and effort.  What It Means to Work at Civia  Every team member plays a crucial role in reshaping clinical research.
  • You’ll help make studies more human-centered, inclusive, and efficient.

    • 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 :

  • Be part of a purpose-led team committed to health equity and real-world impact.  Startup Energy, Proven Expertise : Work fast, adapt quickly, and help build something new; guided by seasoned visionary professionals who’ve seen what needs to change.  People First Culture : We care deeply about our patients, participants, and each other.

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

  • We don’t just hire for today; we’re building the leaders and changemakers of tomorrow.   If you’re ready to be part of something meaningful—and work with people who care deeply about doing good work—apply today by submitting your resume and cover letter to the link above.
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