Fractional VP of Quality

Lindus Health

GCP Quality leader overseeing quality assurance for clinical trials in the US, UK, and EU. Leading audits and ensuring compliance with GCP regulations while managing a small team.

Posted 4/22/2026part-timeRemote • 🇺🇸 United StatesLeadWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead on GCP quality across the business: audit programme design and execution, inspection readiness, and ongoing compliance with ICH GCP
Provide hands-on GCP auditing of trials, sites, vendors, and internal processes - working with clinical operations teams to identify risks and drive corrective actions
Prepare staff and trial materials for external sponsor audits and regulatory inspections, supporting the team through the process and any required follow-up
Assess and advise on potential serious breaches, protocol deviations, and GCP quality issues
Keep current with evolving regulations and guidance
Provide ad-hoc US regulatory and FDA-specific good practice guidance as our US trial portfolio expands
Maintain overall oversight of the Integrated Management System (IMS)
Ensure quality documentation - SOPs, policies, risk assessments - is accurate, current, and practical for the teams using it
Line manage the Business Quality Manager and GCP Quality Associate, ensuring both streams of quality work are resourced, prioritised, and delivering value

Requirements

What you’ll need

Significant hands-on experience in GCP quality assurance, including planning and conducting GCP audits (study, site, vendor, process/system)
Strong working knowledge of ICH GCP (E6 R2/R3), FDA regulations (21 CFR Parts 11, 50, 56, 312), and ideally exposure to EU/UK clinical trial regulations
Experience developing and maintaining a GCP quality management system, including SOPs, CAPA processes, deviation management, and risk assessment
Comfortable providing ad-hoc regulatory and good practice guidance to clinical operations teams
Experience with eQMS platforms (we use Qualio) and understand how to make quality systems practical and usable rather than bureaucratic
Able to manage and develop a small team while staying personally close to the GCP quality work
High agency and a bias for action
Passionate and curious about our mission; changing how the healthcare industry operates

Benefits

Comp & perks

Work on high-impact clinical trials
Collaborate with industry-leading medical professionals and sponsor teams
Enjoy flexible scheduling and project variety
Competitive contractor rates
Leverage our established infrastructure and resources
Work with a stable, well-funded organisation
Contribute your expertise to meaningful research
Receive comprehensive support from our medical team
The flexibility of working as a contractor

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GCP quality assuranceGCP auditsICH GCPFDA regulationsGCP quality management systemSOPsCAPA processesdeviation managementrisk assessmenteQMS

Soft Skills

team managementcommunicationproblem-solvingleadershipadaptabilityattention to detailagencybias for actioncuriositypassion