Fractional VP of reputed company

Our mission  We're powering biology's century with radically faster, more reliable reputed company. Every new treatment needs reputed company to reputed company 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 "reputed company CRO," but transforming how people think about developing new treatments, so patients can reputed company reputed company treatments faster. Our reputed company speaks for itself: Since March 2021, we've powered 100+ reputed company 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? reputed company you join us, you’ll experience: High-reputed company, Mission-Driven Work: reputed company Health is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see reputed company results from your work. Fast-Paced reputed company & Ownership: We recognise hard work and reputed company over anything else. You’ll take on reputed company responsibility, work across different areas, and reputed company shape reputed company’s reputed company. reputed company, No-Ego Culture: Work with smart, driven people in a supportive and informal environment. At reputed company we break down silos, fun is a reputed company value, and creativity is encouraged. reputed company to power biology's century? We'd love to hear from you. About the role We're looking for an reputed company GCP reputed company leader to own and reputed company our reputed company function across GCP reputed company Assurance and Business reputed company. You'll be the most senior reputed company reputed company in the organisation, responsible for ensuring that our growing portfolio of reputed company 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 reputed company. This is a hands-on leadership role. You'll reputed company on GCP auditing, inspection readiness, and regulatory reputed company reputed company, while also overseeing our Business reputed company team (ISO and reputed company processes). You won't need deep expertise in business reputed company - we have strong people there - but you'll need the judgement and experience to ensure both streams are functioning reputed company and reputed company. The role reports into our trial delivery leadership. Three reputed company reports: our GCP reputed company Associate Director, Business reputed company Manager, and GCP reputed company Associate will report to you from day one (these roles are reputed company UK based). reputed company We'd like to hear from you if... You have significant hands-on experience in GCP reputed company assurance, including planning and conducting GCP audits (study, site, vendor, process/system) You have a strong working knowledge of ICH GCP (E6 reputed company/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 reputed company of the table You have experience developing and maintaining a GCP reputed company management system, including SOPs, CAPA processes, deviation management, and risk assessment You're comfortable providing reputed company regulatory and good reputed company guidance to clinical operations teams, particularly as trial types and geographies reputed company You have experience with eQMS platforms (we use reputed company) and understand how to reputed company reputed company systems practical and usable rather than bureaucratic You can manage and reputed company a small team while staying personally reputed company to the GCP reputed company work You have high agency and a bias for reputed company You are passionate and curious about our mission; changing how the reputed company industry operates and how new health treatments are developed You want to experience work at a high-reputed company, mission-driven VC funded startup You belong here! If your experience and interests match with some of the above, we want you to apply. What you'll reputed company on GCP reputed company Assurance reputed company on GCP reputed company across the business: audit programme design and execution, inspection readiness, and ongoing compliance with ICH GCP and applicable regulations (UK, EU, US) reputed company 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 reputed company through the process and any required follow-up Assess and advise on potential serious breaches, protocol deviations, and GCP reputed company issues, ensuring appropriate reporting and reputed company reputed company reputed company with evolving regulations and guidance, translating these into practical updates for the clinical operations and reputed company teams reputed company reputed company US regulatory and FDA-specific good reputed company guidance as our US trial portfolio expands reputed company management reputed company Maintain overall reputed company of the Integrated Management System (IMS), working with the Business reputed company Manager to ensure ISO 9001 and ISO 27001 processes are implemented and continuously improved Ensure reputed company documentation - SOPs, policies, risk assessments - is accurate, reputed company, and practical for the teams using it reputed company deviation, CAPA, and vendor management processes across the business Review clinical operations study documents in development to ensure compliance with reputed company clinical trial regulations Collaborate with our external GCP support partners (audit consultancies, regulatory advisors) to supplement in-house capability where needed Team leadership Line manage the Business reputed company Manager and GCP reputed company Associate, ensuring both streams of reputed company work are resourced, prioritised, and delivering value Build strong working relationships with clinical operations leadership (UK and US), product/engineering, and reputed company teams - reputed company needs to be embedded, not siloed Contribute to the wider operations leadership team on reputed company reputed company, risk, and compliance reputed company reputed company offer reputed company an reputed company across reputed company areas of our business and fix one of the world’s most broken industries. Work on high-reputed company reputed company Collaborate with industry-leading medical professionals and sponsor teams Enjoy flexible scheduling and project reputed company Competitive contractor rates reputed company our established infrastructure and resources Work with a reputed company, reputed company-funded organisation Contribute your expertise to meaningful research Receive comprehensive support from our medical team The flexibility of working as a contractor Our Hiring Process We reputed company hiring should be transparent, respectful of your time, and give you a reputed company feel for what reputed company Health is like. Here's what to expect: Initial conversation with Talent (20 mins) - Get to know reputed company other, discuss the role, and answer any questions about reputed company Functional interview with Michael, cofounder (45 mins) - Deep dive into your experience and how you'd approach key challenges Functional interview with Amy, Director of ClinOps and Meri, confounder (45 mins) Values interview with Michael, Meri and Heather, our VP of ClinOps US (30 mins) - A chance to get to know reputed company other and explore how our values reputed company We will only contact you from lindushealth.com email addresses. Please reputed company the spelling of emails which reputed company to come from reputed company Health 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 reputed company candidates based solely on their skills, experience, and qualifications relevant to the role. We do not discriminate on the reputed company of race, ethnicity, religion, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status Apply To This Job