Executive Director, Global Clinical Quality Assurance

Role Summary

Executive Director, Global Clinical Quality Assurance – Lead the GCP quality and regulatory inspection readiness program for ADCT, serving as the subject matter expert and primary quality partner for all CMO functions. Drive strategic quality initiatives and hands-on execution to ensure readiness for upcoming FDA inspections and ongoing regulatory compliance in a fast-paced biotech environment. This role reports to the SVP, Chief Medical Officer and requires regular in-office presence in New Providence, NJ.

Responsibilities

• Inspection Readiness & Management:
  • Lead end-to-end preparation for anticipated 2026 FDA Pre-Approval Inspection (PAI), including readiness assessments, remediation, and mock inspections
  • Direct all regulatory inspection activities, develop strategy, prepare teams, facilitate mock inspections with external vendors, and serve as primary quality liaison during inspections
  • Ensure inspection readiness across all clinical sites, CROs, and internal functions; drive corrective actions for gaps
  • Establish and maintain inspection readiness scorecards; lead quarterly preparedness reviews with CMO leadership
• Quality System Development & Process Ownership:
  • Develop, implement, and own SOPs and processes for Quality Event Management (classification, escalation, investigation, CAPA)
  • Build scalable quality processes from scratch where gaps exist
  • Design and implement risk-based quality oversight framework for clinical trials in collaboration with Clinical Quality & Risk Management
  • Create and maintain Clinical Quality Manual
• Mock Audits & Vendor Management:
  • Facilitate internal mock audits and inspections; develop scenarios and provide actionable feedback
  • Source, contract, and manage external quality consultants and mock inspection vendors; participate in inspections
  • Conduct post-mock audit gap analyses and drive remediation plans to closure
• GCP Subject Matter Expertise:
  • Serve as go-to GCP expert; provide guidance on complex compliance questions
  • Deliver GCP training to internal teams and CROs; develop training materials
  • Stay current on evolving GCP regulations globally and assess impact on operations
• Strategic & Operational Leadership:
  • Lead with a hands-on approach; tackle complex quality issues and participate in operational execution
  • Balance strategic planning with tactical SOP writing and execution
  • Develop capabilities of the quality function while driving near-term deliverables
• Cross-Functional Partnership:
  • Collaborate with Quality Management on risk-based oversight, metrics, and continuous improvement
  • Align enterprise quality systems with Regulatory Affairs and Clinical Operations; share CAPA trends
  • Serve as primary quality partner for Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, and Drug Safety
  • Oversee Quality Issues, CAPA, Regulatory Strategy & Compliance, Stakeholder Engagement, and Pharmacovigilance Quality Processes
  • Other duties as assigned

Qualifications

• Bachelor‚Äôs degree in Life Sciences, Pharmacy, or related field required; advanced degree preferred
• At least 15 years in clinical quality assurance within global organizations; demonstrated hands-on leadership of multiple regulatory inspections (FDA, EMA, or other authorities); experience in small to mid-size biotech preferred
• Proven track record leading FDA PAI or other high-stakes inspections with documented examples
• Hands-on experience developing quality SOPs and processes from scratch; experience planning, facilitating, and executing mock inspections with external vendors
• Deep GCP expertise; recognized as a subject matter expert
• Quality Assurance certification (e.g., CQA or RQAP-GCP) preferred
• PV Quality experience and hematology/oncology trials experience preferred
• Extensive knowledge of ICH GCP and global regulations; able to apply principles
• Experience with outsourced clinical trials model required
• Leadership style: hands-on, building quality infrastructure, capable of strategic and detailed work; thrives in fast-paced biotech environments; comfortable with ambiguity
• Strong project management and stakeholder alignment skills
• Experience working with external quality consultants and mock inspection vendors
• Ability to translate regulatory findings into actionable improvements
• Track record building quality teams in resource-constrained environments
• Excellent communication and attention to detail; effective cross-functional collaboration
• Ability to travel approximately 15% as needed

Education

• Bachelor‚Äôs degree in Life Sciences, Pharmacy, or related field required; advanced degree preferred