Director of Clinical Quality

Lindus Health

Director overseeing GCP quality for clinical trials at Lindus Health. Leading quality assurance and compliance across US, UK, and EU trial portfolios.

Posted 4/24/2026full-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 and applicable regulations (UK, EU, US)
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, ensuring appropriate reporting and resolution
Keep current with evolving regulations and guidance, translating these into practical updates for the clinical operations and quality teams
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), working with the Business Quality Manager to ensure ISO 9001 and ISO 27001 processes are implemented and continuously improved
Ensure quality documentation - SOPs, policies, risk assessments - is accurate, current, and practical for the teams using it
Oversee deviation, CAPA, and vendor management processes across the business
Review clinical operations study documents in development to ensure compliance with current clinical trial regulations
Collaborate with our external GCP support partners (audit consultancies, regulatory advisors) to supplement in-house capability where needed
Line manage the Business Quality Manager and GCP Quality Associate, ensuring both streams of quality work are resourced, prioritised, and delivering value
Build strong working relationships with clinical operations leadership (US and UK), product/engineering, and commercial teams - quality needs to be embedded, not siloed
Contribute to the wider operations leadership team on quality strategy, risk, and compliance matters

Requirements

What you’ll need

You have at least 10 years of experience in roles overseeing GCP quality assurance, including planning and conducting GCP audits (study, site, vendor, process/system)
You have at least 10 years of experience in roles overseeing ICH GCP (E6 R2/R3), FDA regulations (21 CFR Parts 11, 50, 56, 312), and ideally exposure to EU/UK clinical trial regulations
You've supported or led preparation for regulatory inspections (FDA and ideally EMA) and sponsor audits, ideally from both sides of the table
You have experience developing and maintaining a GCP quality management system, including SOPs, CAPA processes, deviation management, and risk assessment
You're comfortable providing ad-hoc regulatory and good practice guidance to clinical operations teams, particularly as trial types and geographies evolve
You have experience with eQMS platforms (we use Qualio) and understand how to make quality systems practical and usable rather than bureaucratic
You can manage and develop a small team while staying personally close to the GCP quality work
You have high agency and a bias for action
You are passionate and curious about our mission; changing how the healthcare industry operates and how new health treatments are developed
You want to experience work at a high-growth, mission-driven VC funded startup.

Benefits

Comp & perks

Competitive salary plus meaningful equity - you'll own a piece of what we're building
$2,000 annual Learning & Development budget for courses, certifications, and conferences
39 days annual leave (27 days PTO + 11 federal holidays + 1 James Lind Day)
$800 monthly employer contribution for insurance coverage (via Trinet PEO)
$40 monthly wellness allowance with flexibility on how to spend this, including opting in to a company private health insurance or wellhub membership.
Access to gym and retail discounts through Happl
Monthly lunch vouchers for remote team members
Regular company events and team gatherings (both virtual and in-person)
Charity partnerships and volunteering opportunities with Forward Trust

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GCP quality assuranceGCP auditsICH GCPFDA regulationsEU clinical trial regulationsSOP developmentCAPA processesdeviation managementrisk assessmentquality management system

Soft Skills

team managementrelationship buildingcommunicationleadershipproblem-solvingadaptabilitystrategic thinkingcollaborationagencycuriosity

Certifications

ISO 9001ISO 27001