Director of Clinical Quality at Lindus Health

**Who this is for** This role is for a seasoned quality assurance leader with a deep background in GCP and clinical trials who is looking to steer the quality s

Work type: remote

Location: US

Type: Full-time

Summary

**Who this is for** This role is for a seasoned quality assurance leader with a deep background in GCP and clinical trials who is looking to steer the quality strategy for a fast-growing, mission-driven startup. **Key highlights** You will serve as the most senior quality professional at Lindus Health, overseeing both GCP Quality Assurance and Business Quality while leading a team across the US, UK, and EU to ensure regulatory compliance and inspection readiness. **You might be a good fit if you...** - Have 10+ years of experience managing GCP quality assurance, including conducting site, vendor, and system audits. - Possess strong knowledge of FDA regulations (21 CFR Parts 11, 50, 56, 312) and ICH GCP guidelines. - Have successfully led teams through regulatory inspections and developed robust quality management systems. - Are adept at using eQMS platforms like Qualio to create practical, non-bureaucratic processes.

Job Description

🍊Our missionWe're powering biology's century with radically faster, more reliable clinical trials. Every new treatment needs clinical trials to prove safety and efficacy, but today's infrastructure is stuck in the past- driving up cost, causing delays and ultimately meaning new treatments don’t get to patients. We're fundamentally changing that- not just being a "better CRO," but transforming how people think about developing new treatments, so patients can access breakthrough treatments faster.

Our impact speaks for itself: Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. We recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries.

🍊What's it like to work here?

When you join us, you’ll experience:

• High-Impact, Mission-Driven Work:Lindus is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work.

• Fast-Paced Growth & Ownership:We recognise hard work and outcomes over anything else. You’ll take on real responsibility, work across different areas, and actively shape the company’s success.

• Collaborative, No-Ego Culture:Work with smart, driven people in a supportive and informal environment. At Lindus we break down silos, fun is a core value, and creativity is encouraged.

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).

🍊 About youWe'd like to hear from you if...

• 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

🍊 What you'll focus onGCP Quality Assurance

• 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

We believe in rewarding the people who are building the future of clinical research.

Financial & Growth:

• 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](https://wellhub.com/en-uk/) 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

We believe hiring should be transparent, respectful of your time, and give you a real feel for what Lindus Health is like. Here's what to expect:

1. Initial conversation with Cam, our ClinOps Senior Talent Partner (30 mins) - Get to know each other, discuss the role, and answer any questions about Lindus

2. Functional interview with one of our cofounders (45 mins) - Deep dive into your experience and how you'd approach key challenges

3. Functional interview with our VP of ClinOps US and VP of Medical (45 mins) - This will include a task you'll need to prepare in advance of the interview and talk through

4. Values interview with a co-founder and other member of the wider team (30 mins) - A chance to get to know each other and explore how our values align

We will only contact you from[lindushealth.com](http://lindushealth.com)email addresses. Please check the spelling of emails which appear to come from Lindus carefully before responding. We will never ask for your financial information over email.

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

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