Director, Global Clinical Quality Assurance

Description

Transforming Cancer Therapy Together

At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients' lives.

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, conditional approval from the European Commission and conditional approvals in other countries. ZYNLONTA is also being evaluated in combination with other agents and in earlier lines of DLBCL therapy as well as indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reach significantly more patients through expanded use.

We are a team of approximately 150 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re 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.

Job Summary:

The Director, Global Clinical Quality Assurance will provide hands-on execution for ADCTs GCP quality assurance and regulatory inspection readiness program. The role will assist with the implementation of quality strategies, development and maintenance of SOPs and quality processes, mock inspections, audit and inspection preparedness, and resolution of complex compliance issues, including serious breaches. The Director will serve as a GCP subject matter expert and quality partner to Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, Drug Safety, CROs, and clinical sites. This role contributes to ADCTs mission by strengthening compliant, scalable quality systems and supporting reliable clinical trial conduct, patient protection, data integrity, and regulatory readiness. The Director is expected to operate independently in a fast-paced, matrixed biotechnology environment and maintain regular presence in the New Providence, NJ office based on business needs.

What You'll Do:

Job responsibilities may include, but are not limited to:

• Perform GCP audits and contribute to GCP audit schedule development
• Serve as a GCP subject matter expert for ADCT and provide guidance on complex GCP interpretation and compliance questions
• Review, assess and report GCP Serious Breaches
• Deliver GCP training to internal teams and CROs, develop training materials, and facilitate workshops
• Maintain current knowledge of evolving global GCP regulations and assess potential impacts on ADCT operations
• Implement scalable quality processes where gaps exist, applying pragmatic, compliant solutions that meet regulatory requirements and support business objectives
• Develop and maintain the Clinical Quality Manual with direct responsibility for content
• Provide hands-on management of regulatory inspection activities, including developing inspection plans, preparing teams and documentation, facilitating mock inspections with external vendors, and serving as a quality liaison during actual inspections
• Coordinate inspection readiness across clinical sites, CROs, and internal functions, and drive assigned corrective actions when gaps are identified
• Facilitate internal mock audits and inspections, including developing scenarios, conducting interviews, and providing actionable feedback
• Serve as a quality partner for Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, and Drug Safety
• Quality Issue Management & CAPA: Manage the classification of Quality Issues, support critical issue escalation, and oversee assigned CAPA effectiveness activities.
• Regulatory Strategy and Compliance: Collaborate with Regulatory Affairs and Clinical Operations to align quality assurance activities with clinical development plans. Update and adapt quality processes to reflect changes in regulatory standards and best practices
• Maintain regular presence in the New Providence, NJ office, as needed
• Other duties, as assigned

Requirements

Who You Are:

• BS/BA degree, clinical/science degree or certification (e.g. RN, NP, MSN, PharmD, PhD, MD, AS, RTT, MT, etc.), in a scientific or health related discipline.
• Minimum of 10 years of experience in the biopharmaceutical industry or at a Contract Research Organization in Clinical R&D.
• Experience working directly in a clinical quality risk management, quality assurance or GCP auditing role. Experience in these roles at a small biotechnology company is also preferred.
• Experience in hematology/oncology trials is highly 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 required.
• Experience in working in an outsourced model for clinical trials is preferred.
• Experience developing processes, computer systems and training materials to support an effective quality management system.
• Strong project management skills and demonstrated ability to look at the big picture when making decisions and accounting for what may be in the best interest of ADCT.
• Attention to detail with an ability to perform critical review of various types of documents.
• Ability to independently solve problems and facilitate resolution of issues.
• Demonstrated ability to work as a team player with multi-disciplinary project teams.
• Demonstrated ability to work independently but also in a team environment, exercise sound judgment, and adapt to changing work environment(s).
• Excellent verbal, written, and interpersonal communication skills.
• Ability to travel globally up to ~20%.

What We Offer:

• Competitive biotech base salary, annual target bonus (eligibility based on company performance) or quarterly IC (field sales roles) and new hire stock options – so you share in the value you help create
• Medical, Dental and Vision benefits which start on the 1st day of employment
• 401(k) with company match
• Paid time off and company holidays including a company wide shut down at the end of the year
• Paid Parental Leave, Life and Disability Insurance, Tax advantaged health savings and spending accounts
• A hands-on, collaborative culture with other passionate biotech professionals
• Mission-driven work that puts patients first

Join Our Inclusive Team:

ADC Therapeutics is an equal opportunity employer. We are committed to building collaborative, engaged teams and fostering a professional and respectful work environment where employees are empowered for success. We consider all qualified applicants without regard to any characteristic protected by law.