ADC Therapeutics · 1 day ago
Executive Director, Global Clinical Quality Assurance
New Jersey, United States
Full-time
Hybrid
Director/Executive
15+ years expADC Therapeutics is a commercial, global leader in the field of antibody-drug conjugates, seeking an Executive Director of Global Clinical Quality Assurance. This role involves leading the GCP quality and regulatory inspection readiness program, requiring both strategic vision and operational excellence, while ensuring compliance and quality across clinical operations.
BiopharmaBiotechnologyMedicalTherapeutics
Hiring Manager
Sharon L.
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
Accountable for classification of Quality Issues, critical issue escalation and CAPA Effectiveness
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
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
Establish and manage Pharmacovigilance Quality Assurance processes
Other duties as assigned
Qualification
Required
Bachelor's degree in Life Sciences, Pharmacy, or related field is required
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
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
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
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
Ability to travel 15%, as needed, to office locations and for business meetings
Preferred
An advanced degree is preferred
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
Company
ADC Therapeutics
ADC Therapeutics develops antibody drug conjugates and non-antibody drug conjugate products.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.02BKey Investors
TCG CrossoverRedmile GroupDeerfield
2025-10-13Post Ipo Equity· $60M
2025-06-12Post Ipo Equity· $100M
2024-05-06Post Ipo Equity· $105M
Leadership Team
Ameet Mallik
President & CEO
Jose Carmona
Chief Financial Officer
Recent News
Canada NewsWire
2025-12-19
2025-12-11
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