Executive Director, Global Clinical Quality Assurance

Role Summary

Executive Director, Global Clinical Quality Assurance leading the GCP quality and regulatory inspection readiness program for ADCT, with strategic and hands-on responsibilities to ensure inspection readiness, quality systems, and cross-functional collaboration in a fast-paced biotech environment.

Responsibilities

• Lead end-to-end preparation for anticipated FDA Pre-Approval Inspection (PAI) and oversee comprehensive readiness activities, remediation, and mock inspections.
• Direct regulatory inspection activities, develop strategy, prepare teams, coordinate documentation, and serve as primary quality liaison during inspections.
• Ensure inspection readiness across all clinical sites, CROs, and internal functions; drive corrective actions for identified gaps.
• Establish and maintain inspection readiness scorecards; lead quarterly preparedness reviews with executive leadership.
• Develop, implement, and own SOPs and processes for Quality Event Management, including classification, escalation, investigation, and CAPA.
• Build scalable quality processes and implement compliant solutions that meet regulatory requirements and enable business objectives.
• Design and implement risk-based quality oversight framework for clinical trials in collaboration with relevant leaders.
• Create and maintain Clinical Quality Manual with hands-on ownership of content.
• Facilitate internal mock audits and inspections; manage external quality consultants and vendors; participate actively in mock inspections.
• Conduct post-mock audit gap analyses and drive remediation plans to closure.
• Serve as GCP subject matter expert; provide guidance on complex compliance questions and deliver training to internal teams and CROs.
• Stay current on evolving GCP regulations globally and assess impact on operations.
• Model hands-on leadership; tackle complex quality issues, draft critical documents, and execute operational tasks alongside strategic oversight.
• Balance strategic planning with tactical execution; contribute to SOP writing and near-term deliverables.
• Build quality function capabilities and drive near-term critical deliverables.
• Partner with key leaders on risk-based quality oversight, metrics, and continuous improvement; align enterprise quality systems and SOPs; serve as primary quality partner for clinical operations and related functions.
• Oversee Quality Issue Management & CAPA, regulatory strategy and compliance, stakeholder engagement, PV quality, and other assigned duties.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or related field required; advanced degree preferred.
• At least 15 years in clinical quality assurance within a global organization with hands-on leadership of multiple regulatory inspections (FDA, EMA, or others); experience leading inspection preparation, QA lead during inspections, and post-inspection CAPA closure; biotechnology experience preferred.
• Proven track record leading FDA PAI or other high-stakes regulatory inspections with specific 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; ability to provide authoritative guidance.
• Quality Assurance certification such as CQA or RQAP-GCP preferred; PV quality and hematology/oncology trial experience preferred.
• Extensive knowledge of ICH GCP and global regulations; ability to apply principles across regions.
• Experience interacting with inspectors and global cross-functional teams; outsourced clinical trial model experience required.
• Leadership style: hands-on, builder mentality; thrives in dynamic biotech environments; comfortable with ambiguity and pragmatic risk-based decision-making.
• Strong project management skills; ability to manage complex quality initiatives end-to-end.
• Experience working with external quality consultants and mock inspection vendors.
• Excellent communication and collaboration skills; detail-oriented with ability to review diverse documents.
• Willingness to travel approximately 15% as needed.

Skills

• GCP compliance and regulatory inspection management
• Quality event management and CAPA
• SOP development and quality system design
• Risk-based quality oversight for clinical trials
• Vendor management and mock inspections
• Cross-functional collaboration and stakeholder management

Education

• Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred

Additional Requirements

• Willingness to travel up to 15% as needed