Location: Remote, UK 

Job Type: Full Time

Reports to: VP, Quality
 

Join Us at Civia Health

At Civia Health, we’re reimagining how clinical trials are delivered by putting patients first and empowering providers to lead innovation. We are seeking an experienced Quality Manager to lead and support regulatory activities across multiple clinical trial sites and vendors, with a deep understanding on UK regulations. The role will own the start-to-end lifecycle of regulatory documentation, including preparation, submission, tracking, and archival, ensuring audit-readiness at all times. This is a pivotal role within our Quality team, offering the opportunity to work across diverse therapeutic areas and geographies.

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 participants. 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

• Serve as the primary quality contact for UK locations, liaising with internal stakeholders and external partners. 
• Conducts regular on-site audits of our UK sites including affiliated and integrated sites, ensurance compliance ready
• Acts as the expert and SME in all quality and regulatory with specific deep knowledge in UK requirements and processes including The Health and Safety Executive
• Manage vendor qualification process for UK specific vendors
• Prepares, reviews and submits regulatory documents to Sponsor/CRO to support their MRHA and EC submissions.
• Partner with sponsor/CRO to manage safety-related communications and submissions, including Serious Adverse Events (SAEs) and protocol deviations.
• Ensure timely reporting and documentation in accordance with global regulations.
• Maintain and manage electronic Investigator Site Files (eISF) and on-site documentation by ensuring all essential trial documentation is accurately organized, version-controlled, and continuously updated to remain inspection-ready throughout the entire clinical trial lifecycle. This includes monitoring compliance with regulatory requirements, performing periodic quality checks, and promptly addressing any discrepancies to support audit and regulatory review readiness. 
• Develop, maintain, and update Delegation of Authority logs for all UK clinical trial sites in alignment with protocol and regulatory standards.
• Provide comprehensive support for monitoring visits, internal quality audits, external regulatory inspections, and sponsor oversight activities by ensuring timely preparation of required documentation, facilitating site readiness, addressing findings promptly, and maintaining compliance with Good Clinical Practice (GCP) and applicable regulatory standards.
• Work closely with sponsors, CROs, medical teams, QA, and operations to help manage deviations and Corrective and Preventive Actions (CAPAs).

What You Bring

• 5–7 years of Quality experience in clinical research, ideally within a CRO, pharma, or biotech environment. 
• Bachelor’s degree in life sciences or related field (advanced degree preferred).
• Travel expectations to sites, expected 30%
• Success in supporting health authority inspections (FDA, EMA, MHRA), including inspection preparation, participation, and follow-up
• Strong understanding of ICH-GCP, global clinical trial regulations, and global regulatory frameworks. Experience managing multi-site studies and working with multiple vendors. 
• Proven experience with UK MHRA submissions and IRB/ethics committee processes and HSE
• Excellent communication, project management, and organizational skills. 
• Ability to work independently and collaboratively in a fast-paced, global environment. 

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. We’re excited to learn more about you!