Fractional VP of Quality

Lindus Health

About The Position

We are seeking an experienced GCP quality leader to take ownership and lead our Quality function, encompassing both GCP Quality Assurance and Business Quality. This individual will serve as the most senior quality professional within the organization, responsible for ensuring that our expanding portfolio of clinical trials across the US, UK, and EU adheres to the highest standards of GCP compliance. Additionally, they will ensure our integrated management system continues to effectively support the business as it scales. This is a hands-on leadership role, involving leadership in GCP auditing, inspection readiness, and regulatory quality matters, while also overseeing the Business Quality team (ISO and related processes). While deep expertise in business quality is not required, the role demands the judgment and experience to ensure both quality streams function well and are aligned. This position reports into our trial delivery leadership and will have three direct reports from day one: a GCP Quality Associate Director, a Business Quality Manager, and a GCP Quality Associate, all of whom are UK-based.

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)
Supported or led preparation for regulatory inspections (FDA) and sponsor audits
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
Can 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
Want to experience work at a high-growth, mission-driven VC funded startup

Nice To Haves

Exposure to EU/UK clinical trial regulations
Supported or led preparation for regulatory inspections (ideally EMA) and sponsor audits, ideally from both sides of the table

Responsibilities

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 (UK and US), 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

Make an impact across all areas of our business and fix one of the world’s most broken industries.
Work on high-impact clinical trials
Collaborate with industry-leading medical professionals and sponsor teams
Enjoy flexible scheduling and project variety
Competitive contractor rates
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
The flexibility of working as a contractor