Quality Manager

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 of 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.

What You’ll Do

• Serve as the primary quality contact for UK locations, liaising with internal stakeholders and external partners.
• Conduct regular on‑site audits of our UK sites including affiliated and integrated sites, ensuring compliance readiness.
• Act as the expert and SME in all quality and regulatory matters with specific deep knowledge of UK requirements and processes, including the Health and Safety Executive.
• Manage vendor qualification processes for UK‑specific vendors.
• Prepare, review, and submit regulatory documents to Sponsor/CRO to support their MHRA 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.
• 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.
• 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.

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!