Lindus Health
Lindus Health is a company that powers biology’s century by fundamentally changing how people think about developing new treatments, so patients can access breakthrough treatments faster. They are looking for an experienced GCP quality leader to own and lead their Quality function across GCP Quality Assurance and Business Quality.
Requirements
- Significant hands-on experience in GCP quality assurance, including planning and conducting GCP audits
- 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
- Ability to manage and develop a small team while staying personally close to the GCP quality work
- High agency and a bias for action
- Passion and curiosity about the company’s mission and changing the healthcare industry
- Experience with eQMS platforms (Qualio) and understanding how to make quality systems practical and usable
- Ability to provide ad-hoc regulatory and good practice guidance to clinical operations teams
- Ability to assess and advise on potential serious breaches, protocol deviations, and GCP quality issues
Benefits
- Competitive contractor rates
- Flexible scheduling and project variety
- 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
Originally posted on Himalayas
To apply for this job please visit himalayas.app.
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