Director of Clinical Quality

Lindus

19h

About The Position

We are seeking an experienced GCP quality leader to own and lead our Quality function across GCP Quality Assurance and Business Quality. This is a senior role responsible for ensuring our clinical trials meet the highest standards of GCP compliance and that our integrated management system supports business growth. The role is hands-on, involving leadership in GCP auditing, inspection readiness, and regulatory quality matters, as well as overseeing the Business Quality team (ISO and related processes). The position reports into the trial delivery leadership and will have three direct reports: GCP Quality Associate Director, Business Quality Manager, and GCP Quality Associate.

Requirements

At least 10 years of experience in roles overseeing GCP quality assurance, including planning and conducting GCP audits (study, site, vendor, process/system).
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.
Experience supporting or leading preparation for regulatory inspections (FDA and ideally EMA) and sponsor audits, ideally from both sides of the table.
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, particularly as trial types and geographies evolve.
Experience with eQMS platforms (Qualio is used) and understanding how to make quality systems practical and usable rather than bureaucratic.
Ability 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 the mission of changing how the healthcare industry operates and how new health treatments are developed.
Desire to experience work at a high-growth, mission-driven VC funded startup.

Responsibilities

Lead on GCP quality across the business, including audit program 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 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.
Contribute to the wider operations leadership team on quality strategy, risk, and compliance matters.