Director Audits & Inspections - Legal: Risk & Compliance

Careers Signant Health

About The Position

At Signant Health, we help bring life-changing treatments to patients faster. We are a global evidence generation company that supports clinical trials with smart technology, scientific expertise, and hands-on operational support — so better data leads to better decisions in healthcare. We embrace AI and advanced technologies to enhance every aspect of what we do, from data analysis to operational efficiency. We are committed to the growth and development of our people and pride ourselves on a collaborative, inclusive culture. About the Role The Director of Audits & Inspections is a senior member of the Quality Leadership Team, responsible for protecting Signant Health's compliance posture through a risk-based audit and inspection program spanning internal audits, client/regulatory inspections, quality agreements, and supplier GxP qualification. Operating as both practitioner and program leader, the Director partners across Quality, Product, R&D, IT, Legal, and Commercial to ensure Signant's systems, processes, and partners meet the expectations of global health authorities and sponsor clients.

Requirements

Minimum 10 years of progressive leadership experience in Quality, Compliance, or Regulatory Affairs within a GxP-regulated environment; 15+ years total industry experience
Deep knowledge of global GxP frameworks applicable to clinical trial technology: ICH E6(R3), 21 CFR Parts 11 and 820, EU Annex 11, GAMP 5, MHRA GxP Data Integrity guidance, and evolving AI/ML regulatory expectations
Demonstrated experience owning regulatory authority inspections (FDA, EMA, MHRA, or equivalent) from readiness through response closure, with a proven track record designing risk-based audit programs across internal, client/sponsor, and supplier audit types
Excellent written and verbal communication skills — including authoring regulatory authority inspection responses, serious breach assessments, and CAPA commitment submissions to FDA, EMA, MHRA, and equivalent global health authorities, as well as executive briefings and client-facing communications — and the ability to influence without authority across Signant functions
Ability to operate with authority and composure during live regulatory inspections and high-stakes client audits, synthesizing audit data into systemic risk themes for executive and regulatory audiences
Experience with eClinical technology systems (RTSM, eCOA, eConsent, or equivalent) and their data integrity/audit trail requirements, and proven ability to lead teams through regulatory complexity and organizational change

Nice To Haves

Experience in a software-as-a-service (SaaS) clinical technology organization, with knowledge of Computer Systems Validation (CSV) and data integrity principles under ALCOA+
Familiarity with AI/ML governance expectations in GxP contexts, including emerging EU AI Act implications for high-risk clinical trial systems
Certified Quality Auditor (CQA), ASQ, or equivalent, with experience contributing to industry working groups or regulatory consultation processes

Responsibilities

Own and continuously mature a risk-based internal audit program aligned with ICH E6(R3), 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable GxP frameworks, executing an annual schedule prioritized by compliance risk and strategic importance
Analyze audit outcomes to identify systemic root causes and escalate emerging risk themes to Quality leadership and relevant stakeholders
Lead internal audits across product/platform delivery and operational processes, documenting findings with precision and proportionality
Drive finding closure through partnership with process owners and the CAPA program to verified effectiveness, analyzing outcomes to escalate systemic risk themes to Quality leadership
Oversee the client audit team facilitating sponsor/client-initiated audits and regulatory authority inspections (FDA, EMA, MHRA, and other global health authorities)
Lead inspection readiness (mock inspections, gap assessments, cross-functional drills) and manage the end-to-end inspection lifecycle — preparation, on-site/remote hosting, SME coordination, and commitment closure
Maintain an enterprise-level tracker for real-time Quality leadership visibility, and act as a calm, authoritative presence during live inspections that builds trust with regulatory authorities and clients
Own the supplier/vendor GxP qualification and oversight program (ICH E6(R3) Section 5), designing risk-based supplier audits (remote and on-site) and confirming remediation closure
Support procurement decisions with timely GxP qualification input, and maintain Signant's approved supplier register audit-ready at all times
Serve as the Quality function's SME for Quality Agreements and quality-related MSA provisions, ensuring contractual commitments are enforceable, proportionate, and aligned with Signant's QMS obligations
Review and negotiate quality agreement language with sponsors and vendors alongside Legal and Commercial, escalating high-risk provisions and maintaining a register of active agreements with documented periodic review
Lead, develop, and performance-manage the Audits & Inspections team (8–9 professionals, direct and indirect), setting clear priorities, objectives, and metrics while fostering a culture of rigor, continuous improvement, and psychological safety
Drive career development planning, regular 1:1s, and capability building across the team, empowering both strategic ownership and tactical execution at every level
Partner with Process Standards & Compliance on CAPA oversight and with Quality Business Partners to integrate audit intelligence into client and account risk monitoring
Contribute audit and inspection insights to Quality Management Reviews, ELT, and Board-level reporting, championing a risk-based, proportionate approach to compliance that protects patient safety and data integrity while enabling operational agility