Vp Jobs

About The Position

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), 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 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 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

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

• Competitive salary plus meaningful equity
• $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) - pro-rata to your weekly engagement
• $800 monthly employer contribution for insurance coverage
• $40 monthly wellness allowance
• Enhanced parental leave: 16 weeks full pay for primary caregivers, 6 weeks for secondary
• 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