ADC Therapeutics SA
Executive Director, Global Clinical Quality Assurance
ADC Therapeutics SA, New Providence, New Jersey, us, 07974
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Executive Director, Global Clinical Quality Assurance WFH Flexible New Providence, NJ Clinical & Medical Development
Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.
Why ADC Therapeutics
ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody?drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD?19?directed ADC for relapsed/refractory non?Hodgkin lymphoma, ZYNLONTA (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other anti?cancer therapeutics and in earlier lines of therapy to determine if it has potential to treat an even broader range of patients. In addition to ZYNLONTA, ADC Therapeutics has a PSMA?targeting ADC in ongoing development. We are a team of approximately 200 patient?focused, purpose?driven employees with a shared mission to transform the treatment paradigm for patients. If youre interested in making a difference in the lives of patients worldwide with a team of like?minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn. Position Overview
As the Executive Director of Global Clinical Quality Assurance, this position will be the strategic leader and hands?on driver of ADCT's GCP quality and regulatory inspection readiness program. This role demands both strategic vision and operational excellencethe candidate must operate effectively at both the enterprise strategy level and in the operational details, whether that's developing quality strategies or directly building SOPs, leading mock inspections, and resolving complex compliance issues. With Phase III trial completing a critical regulatory milestone and an anticipated FDA inspection in 2026, this role is mission?critical to ADCT's success. This role will serve as the GCP subject matter expert and primary quality partner for all CMO functions, leading audit and inspection preparedness while building scalable quality systems. This role requires substantial hands?on experience successfully managing US and international regulatory inspections, deep GCP expertise, and the ability to drive results in a fast?paced, matrixed biotech environment. This position reports to the SVP, Chief Medical Officer. This is a hybrid role with the expectation of regular in?office presence in our New Providence, NJ office, anticipated to be at least a few days each month or as business needs require. Job Responsibilities
Inspection Readiness & Management
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 activitiesdevelop 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 Quality System Development & Process Ownership
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 existimplement 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 GCP Subject Matter Expertise
Serve as the go?to GCP expert for ADCTprovide 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 Strategic & Operational Leadership
Model a "sleeves?rolled?up" leadership stylepersonally 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 Cross?Functional Partnership
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 inspectionscan 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 expertiserecognized 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 exampleactively engages in execution rather than solely directing from above. "Builder" mentalitycomfortable 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. Ability to travel 15%, as needed, to office locations and for business meetings. ADC Therapeutics is proud to be an Affirmitive Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success. #J-18808-Ljbffr
ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody?drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD?19?directed ADC for relapsed/refractory non?Hodgkin lymphoma, ZYNLONTA (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other anti?cancer therapeutics and in earlier lines of therapy to determine if it has potential to treat an even broader range of patients. In addition to ZYNLONTA, ADC Therapeutics has a PSMA?targeting ADC in ongoing development. We are a team of approximately 200 patient?focused, purpose?driven employees with a shared mission to transform the treatment paradigm for patients. If youre interested in making a difference in the lives of patients worldwide with a team of like?minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn. Position Overview
As the Executive Director of Global Clinical Quality Assurance, this position will be the strategic leader and hands?on driver of ADCT's GCP quality and regulatory inspection readiness program. This role demands both strategic vision and operational excellencethe candidate must operate effectively at both the enterprise strategy level and in the operational details, whether that's developing quality strategies or directly building SOPs, leading mock inspections, and resolving complex compliance issues. With Phase III trial completing a critical regulatory milestone and an anticipated FDA inspection in 2026, this role is mission?critical to ADCT's success. This role will serve as the GCP subject matter expert and primary quality partner for all CMO functions, leading audit and inspection preparedness while building scalable quality systems. This role requires substantial hands?on experience successfully managing US and international regulatory inspections, deep GCP expertise, and the ability to drive results in a fast?paced, matrixed biotech environment. This position reports to the SVP, Chief Medical Officer. This is a hybrid role with the expectation of regular in?office presence in our New Providence, NJ office, anticipated to be at least a few days each month or as business needs require. Job Responsibilities
Inspection Readiness & Management
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 activitiesdevelop 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 Quality System Development & Process Ownership
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 existimplement 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 GCP Subject Matter Expertise
Serve as the go?to GCP expert for ADCTprovide 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 Strategic & Operational Leadership
Model a "sleeves?rolled?up" leadership stylepersonally 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 Cross?Functional Partnership
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 inspectionscan 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 expertiserecognized 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 exampleactively engages in execution rather than solely directing from above. "Builder" mentalitycomfortable 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. Ability to travel 15%, as needed, to office locations and for business meetings. ADC Therapeutics is proud to be an Affirmitive Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success. #J-18808-Ljbffr