Job Overview
Location
US
Job Type
Part-time
Category
HR & Recruiting
Date Posted
April 24, 2026
Full Job Description
đź“‹ Description
- • Lead the Quality function as the most senior quality professional, ensuring GCP compliance across clinical trials in the US, UK, and EU while supporting scalable quality systems.
- • Conduct hands-on GCP auditing of trials, sites, vendors, and processes; prepare for regulatory inspections; and advise on deviations, breaches, and CAPA to maintain compliance.
- • Oversee the Integrated Management System (IMS), including ISO 9001 and ISO 27001, ensuring documentation is practical and continuously improved.
- • Line manage the Business Quality Manager and GCP Quality Associate, aligning GCP and Business Quality streams and embedding quality across clinical operations, product, engineering, and commercial teams.
- • Join a mission-driven, high-growth startup transforming clinical trials to accelerate patient access to breakthrough treatments, with a collaborative, no-ego culture and ownership mindset.
- • Develop expertise in global clinical trial regulations, eQMS platforms (Qualio), and quality leadership while contributing to strategy in a fast-paced, VC-backed environment.
🎯 Requirements
- • 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 supporting or leading preparation for regulatory inspections (FDA and ideally EMA) and sponsor audits, from both sides of the table
- • Experience developing and maintaining a GCP quality management system, including SOPs, CAPA processes, deviation management, and risk assessment
- • Comfort providing ad-hoc regulatory and good practice guidance to clinical operations teams as trial types and geographies evolve
- • Experience with eQMS platforms (we use Qualio) and ability to make quality systems practical and usable
- • Ability to manage and develop a small team while staying personally close to GCP quality work
- • High agency and bias for action
- • Passion for Lindus Health’s mission to transform clinical trial infrastructure and accelerate patient access to treatments
🏖️ Benefits
- • Competitive salary plus meaningful equity ownership
- • $2,000 annual Learning & Development budget for courses, certifications, and conferences
- • 39 days annual leave (27 PTO + 11 federal holidays + 1 James Lind Day), pro-rata to engagement
- • $800 monthly employer contribution for insurance coverage
- • $40 monthly wellness allowance for gym, massage, or wellbeing activities
- • Enhanced parental leave: 16 weeks full pay for primary caregivers, 6 weeks for secondary
- • Monthly lunch vouchers for remote team members and access to gym/retail discounts via Happl
- • Regular company events, charity partnerships, and volunteering opportunities with Forward Trust
Skills & Technologies
About Lindus Health
Lindus Health is a clinical research technology company dedicated to making clinical trials faster, more efficient, and more accessible. They offer a comprehensive platform that integrates various aspects of clinical trial management, from patient recruitment and engagement to data collection and analysis. Their solutions aim to streamline workflows for researchers, sponsors, and participants, reducing administrative burdens and accelerating the path from discovery to approved treatments. By leveraging technology, Lindus Health seeks to improve the quality of research, reduce trial costs, and ultimately bring life-changing therapies to patients more quickly. Their focus is on innovation within the clinical research space.
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