[Hiring] Director of Clinical Quality @Lindus

Role Description

We're looking for an experienced GCP quality leader to own and lead our Quality function across GCP Quality Assurance and Business Quality. You'll be the most senior quality professional in the organisation, responsible for ensuring that our growing portfolio of clinical trials across the US, UK, and EU meet the highest standards of GCP compliance, and that our integrated management system continues to support the business as we scale.

This is a hands-on leadership role. You'll lead on GCP auditing, inspection readiness, and regulatory quality matters, while also overseeing our Business Quality team (ISO and related processes). You won't need deep expertise in business quality - we have strong people there - but you'll need the judgement and experience to ensure both streams are functioning well and aligned.

The role reports into our trial delivery leadership. Three direct reports: our GCP Quality Associate Director, Business Quality Manager, and GCP Quality Associate will report to you from day one (these roles are all UK based).

Qualifications

• 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 (we use Qualio) and understand 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 our mission; 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.

Requirements

• 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.

Benefits

• 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.
• Work with a team that's genuinely changing healthcare for the better.

Company Description

We are an equal opportunity employer committed to building a diverse and inclusive workforce. We evaluate all candidates based solely on their skills, experience, and qualifications relevant to the role. We do not discriminate on the basis of race, ethnicity, religion, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status.