Executive Director, Global Clinical Quality Assurance

Role Summary

Executive Director of Global Clinical Quality Assurance, serving as the strategic leader and hands-on driver of the GCP quality and regulatory inspection readiness program. Operates at both the enterprise strategy level and in the operational details, developing quality strategies, building SOPs, leading mock inspections, and resolving complex compliance issues. With a Phase III trial milestone and an anticipated FDA inspection, this role is mission-critical to success.

Responsibilities

• Lead end-to-end preparation for anticipated 2026 FDA Pre-Approval Inspection (PAI), including comprehensive inspection readiness assessments, remediation activities, and mock inspection execution
• Hands-on leadership of all regulatory inspection activities—develop inspection strategy, prepare teams and documentation, facilitate mock inspections with external vendors, and serve as primary quality liaison during actual inspections
• Accountable for inspection readiness across all clinical sites, CROs, and internal functions; personally drive corrective actions when gaps are identified
• Establish and maintain inspection readiness scorecards and lead quarterly inspection preparedness reviews with CMO leadership
• Develop, implement, and own SOPs and processes for Quality Event Management, including classification, escalation, investigation, and CAPA processes
• Build scalable quality processes from the ground up where gaps exist—implement pragmatic, compliant solutions that meet regulatory requirements and enable business objectives
• Design and implement risk-based quality oversight framework for clinical trials in collaboration with Director, Clinical Quality & Risk Management
• Create and maintain Clinical Quality Manual with hands-on ownership of content
• Directly facilitate internal mock audits and inspections, including developing scenarios, conducting interviews, and providing actionable feedback
• Source, contract, and manage external quality consultants and mock inspection vendors; actively participate in mock inspections rather than delegating entirely
• Conduct post-mock audit gap analyses and personally drive remediation plans to closure
• Serve as the go-to GCP expert for ADCT—provide authoritative guidance on complex GCP interpretation and compliance questions
• Deliver GCP training to internal teams and CROs; develop training materials and facilitate workshops
• Stay current on evolving GCP regulations globally and proactively assess impact on ADCT operations
• Model a "sleeves-rolled-up" leadership style—personally tackle complex quality issues, draft critical documents, and participate in operational execution alongside strategic oversight
• Balance strategic planning with tactical execution; comfortable switching between enterprise strategy discussions and detailed SOP writing
• Build the quality function's capabilities while personally driving near-term critical deliverables
• Partner with Director, Clinical Quality & Risk Management on risk-based quality oversight, quality metrics, and continuous improvement initiatives
• Collaborate with VP, Global Quality Assurance on enterprise quality system alignment, joint SOPs, and shared CAPA trending
• Serve as primary quality partner for Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, and Drug Safety
• Quality Issue Management & CAPA: Accountable for classification of Quality Issues, critical issue escalation and CAPA Effectiveness
• Regulatory Strategy and Compliance: Collaborate with regulatory affairs and clinical operations to align quality assurance strategies with overall clinical development plans. Ensure continuous update and adaptation of quality processes to reflect changes in regulatory standards and best practices
• Stakeholder Engagement: Serve as the primary clinical quality assurance liaison with regulatory authorities, partners, and internal stakeholders. Ensure transparent communication and collaboration on GCP quality-related matters
• PV Quality: Establish and manage Pharmacovigilance Quality Assurance processes
• Other duties as assigned

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or related field is required. An advanced degree is preferred.
• At least 15 years of experience in clinical quality assurance within a global organization with demonstrated hands-on leadership of multiple successful regulatory inspections (FDA, EMA, or other health authorities). Must have personally led inspection preparation activities, participated as QA lead during inspections, and driven post-inspection CAPA closure. Experience in a small to mid-size biotechnology company strongly preferred.
• Proven track record leading successful FDA Pre-Approval Inspections (PAI) or other high-stakes regulatory inspections—can articulate specific examples of inspection challenges overcome
• Hands-on experience developing quality SOPs and processes from scratch, not just managing existing systems
• Direct experience planning, facilitating, and executing mock regulatory inspections with external vendors
• Deep, demonstrable GCP expertise—recognized as a subject matter expert who can provide authoritative guidance on complex compliance questions
• Certification in Quality Assurance such as CQA or RQAP-GCP preferred
• Experience with PV Quality preferred
• Experience in hematology/oncology trials preferred
• Extensive knowledge of ICH GCP and relevant global regulations and guidelines with the ability to apply the principles
• Experience interacting with inspectors and cross-functional, global teams is strongly preferred
• Experience in working with an outsourced model for clinical trials is required
• Leadership style: Hands-on, action-oriented leader who drives by example—actively engages in execution rather than solely directing from above. "Builder" mentality—comfortable creating quality infrastructure and processes in environments where they don't yet exist. Equally effective in strategic planning sessions and in detailed document review/SOP writing. Thrives in dynamic, fast-paced biotech environments with competing priorities. Comfortable with ambiguity; able to make pragmatic, risk-based decisions when perfect information isn't available
• Strong project management skills with the ability to manage complex clinical quality initiatives from end-to-end, ensuring timelines, deliverables, and stakeholder alignment
• Experience working directly with external quality consultants and mock inspection vendors required
• Demonstrated ability to translate regulatory inspection findings into actionable quality improvements
• Track record of building quality teams and capabilities in resource-constrained environments
• Excellent communication skills, capable of effectively presenting and discussing complex issues to influence outcomes
• Attention to detail with an ability to perform critical review of various types of documents
• Demonstrated ability to work as a team player with multi-disciplinary project teams

Additional Requirements

• Travel: Ability to travel 15%, as needed, to office locations and for business meetings